Dermadex

Benzoic Acid:

• Precautions
• Instructions for use
• Dermadex (Benzoic Acid) reviews

Precautions

• Flammable
• Do not expose to temperatures exceeding 50°C
• Do not spray near naked flame
• Keep container tightly closed
• Only use this product in a well ventilated area
• Do not breathe mist or spray
• In case of contact with eyes rinse immediately with plenty of water and seek medical advice
• If swallowed seek medical advice and show this label

• For external use only
• For animal use only

• Keep out of reach of children

Ingredients

E124, E133, Ethanol, Organic Acids (Acetic and Dermadex (Benzoic Acid)), Polyvinylpyrrolidone, Tea-tree Oil, Triacetin, Water

Instructions for use

• For use in sheep, cattle, horses and goats

• Clean and dry hooves thoroughly before use
• Pare hoof if necessary
• Shake container well and spray liberally
• Allow 1-2 minutes for the Combat film to form, before returning hoof to the ground
• For severe cases in sheep repeat application every 2 days for 1 week
• For severe cases in cattle apply several layers of Combat after each milking for up to 10 days

NB: Always separate sheep with hoof problems from those without

Combat Footspray should be used as part of a routine footcare programme. Ideally use in conjunction with regular footbathing with Provita Hoofsure/Hoofsure Endurance.

Provita

ANIMAL HEALTH NATURALLY

Combat

The Longer Lasting

Foot Spray for

Livestock

A unique film forming spray

containing tea tree oil and

organic acid providing a

persistent longer lasting

antiseptic barrier for hooves

Benzyl Benzoate:

• Active ingredients
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Dermadex (Benzyl Benzoate) reviews

Active Ingredients

Dermadex Alcohol 10%

Camphor 0.6%

Menthol 0.4%

Purpose

External Analgesic

Uses

for the temporary relief of itching associated with insect bites and minor skin irritations.

Warnings

For external use only.

Do not use

• face or genital areas
• on a reas of blistered or broken skin
• with a compress after application

When using this product

do not get into eyes if contact occurs, flush eyes with water

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

• Apply to affected area not more than 3 times daily.
• Children under 2 years of age: do not use, ask a doctor.
• Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.
  

• Test product on small patch of skin before applying to the entire body.

Other information

• Store at room temperature.
• You may report a serious adverse reaction to Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222.
  

Inactive Ingredients

Water, Structure XL, Cutina GMS, Phenoxol T, Cremaphor CO 40, Butylene Glycol, Zinc Acetate, Steareth-2,

Steareth-20, Steareth 100, Proaqua ISL, Pelemol IPM, Estol 1543, Glydant Plus, Dimethicone, VE Acetate, Allantoin.

Made in the U.S.A. for:

IVY-DRY, INC.

299-B Fairfield Ave.

Fairfield, NJ 07070

©2012 Ivy-Dry, Inc.

Questions or Comments

www.ivydry.com

If you get Poison Ivy,

you know you’ll want

to use a product with

proven effectiveness

that you can trust.

Look no further than

Dermadex (Benzyl Benzoate) Products

known and trusted

for over 60 years.

TEMPORARY

RELIEF

OF PAIN

AND ITCHING

Associated with Minor Skin

Irritations and Insect Bites

External Analgesic

Dermadex (Benzyl Benzoate) Cream Dermadex (Benzyl Benzoate) Cream

Lindane:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• References
• Medication guide
• Dermadex (Lindane) reviews

INDICATIONS AND USAGE

Dermadex (Lindane) Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:

• cannot tolerate other approved therapies, or
• have failed treatment with other approved therapies.

Dermadex (Lindane) Lotion should be used in the context of an overall scabies management program that includes:

• Microscopic evaluation of skin scrapings to confirm the diagnosis.
• Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Dermadex (Lindane) Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
• Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned.

Caregivers applying this product to patients should wear gloves less permeable to Dermadex (Lindane), such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Dermadex (Lindane).

Dermadex (Lindane) Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.

CONTRAINDICATIONS

Dermadex (Lindane) Lotion is contraindicated for premature infants because their skin may be more permeable than that of full term infants and their liver enzymes may not be sufficiently developed to metabolize Dermadex (Lindane).

Dermadex (Lindane) Lotion is also contraindicated for patients with crusted (Norwegian) scabies and other skin conditions (e.g., atopic dermatitis, psoriasis) that may increase systemic absorption of the drug.

Dermadex (Lindane) Lotion is contraindicated for patients with known uncontrolled seizure disorders and for individuals with a known sensitivity to the product or any of its components.

WARNINGS

Seizures and deaths have been reported following Dermadex (Lindane) Lotion's use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. It is not known how soon after application of a single dose of Dermadex (Lindane) Lotion that a second dose of Dermadex (Lindane) Lotion can be safely applied.

There have been cases of adverse events reported for Dermadex (Lindane) Lotion and Dermadex (Lindane) Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.⁴ In approximately 20% of the total reported cases, Dermadex (Lindane) Lotion and Shampoo were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many cases which were remote from the time of actual Dermadex (Lindane) use. Dermadex (Lindane) toxicity, verified by autopsy was the cause of one infant's death, was the cause of death reported for an adult who ingested it orally in a successful suicide. The direct causes of death for the other cases were attributed to reasons other than Dermadex (Lindane). Most of these adverse events occurred with Dermadex (Lindane) Lotion.

Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 110 lbs (50 kg) may be at greater risk of serious neurotoxicity. Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.

Careful consideration should be given before prescribing Dermadex (Lindane) Lotion to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold.

Patients should be instructed on proper use of Dermadex (Lindane) Lotion, especially the amount to apply, how long to leave the lotion on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.

A Dermadex (Lindane) Lotion Medication Guide must be given to the patient each time Dermadex (Lindane) Lotion is dispensed, as required by law.

PRECAUTIONS

General

Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.

Information for Patients

• This product can be poisonous if misused.
• Other important information is found in the Medication Guide, which by law, must be dispensed with Dermadex (Lindane) Lotion.
• If someone other than the patient will be applying Dermadex (Lindane) Lotion to the patient, they should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex gloves should be avoided because they are more permeable to Dermadex (Lindane).
• If the person applying Dermadex (Lindane) Lotion could be pregnant, contact with Dermadex (Lindane) Lotion should be avoided as much as possible.
• If the patient could be pregnant, other treatments may be preferable.
• Dermadex (Lindane) Lotion should be used for scabies only.
• The skin should be clean and without any other lotion, cream, or oil on it. Oils can make the Dermadex (Lindane) Lotion go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).
• Wait at least 1 hour after bathing or showering before putting Dermadex (Lindane) Lotion on the skin. Wet or warm skin can make the Dermadex (Lindane) Lotion go through skin faster.
• Information for Use:
  • Shake Dermadex (Lindane) Lotion well.
  • Put Dermadex (Lindane) Lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Dermadex (Lindane) Lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
  • Use only a single application, applied as a very thin layer over all skin from the neck down.
  • Close the bottle with the leftover Dermadex (Lindane) Lotion and immediately throw it away in a trash can out of the reach of children.
  • Do not use any covering over the applied Dermadex (Lindane) Lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
  • Wash the Dermadex (Lindane) Lotion completely off after 8 to 12 hours. Never leave Dermadex (Lindane) Lotion on the skin for more than 12 hours. Warm, but not hot water can be used. Dermadex (Lindane) Lotion will not kill any more scabies after 8 to 12 hours, but may cause serious health problems.
  • Keep Dermadex (Lindane) Lotion away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if you have open wounds, cuts or sores that are present, unless specifically directed by the prescribing physician.
  • All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • The patient may still itch after using Dermadex (Lindane) Lotion. This does not mean the medicine did not work. Even after all the scabies (mites) are dead, they can still make the skin itch for a few weeks. Dermadex (Lindane) Lotion sometimes makes this itch even worse. Other treatments can be used to soothe the itch. Do not use more Dermadex (Lindane) Lotion.
  • The patient should contact the physician with any questions or concerns about his or her condition or use of the Dermadex (Lindane) Lotion.

Drug Interactions

Oils may enhance absorption of Dermadex, therefore, patients or caregivers applying Dermadex (Lindane) Lotion should be warned about simultaneous use of creams, ointments, or oils. In addition, there are many drugs that may lower the seizure threshold, and Dermadex (Lindane) Lotion should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:

• Antipsychotics
• Antidepressants
• Theophylline
• Cyclosporine, mycophenolate mofetil, tacrolimus capsules
• Penicillins, imipenem, quinolone antibiotics
• Chloroquine sulfate, pyrimethamine
• Isoniazid
• Meperidine
• Radiographic contrast agents
• Centrally active anticholinesterases
• Methocarbamol

Carcinogenesis, Mutagenesis, and Fertility

Although no studies have been conducted with Dermadex (Lindane) Lotion, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane as well as the alpha, beta, gamma (lindane) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of Dermadex (Lindane). The results of mutagenicity tests in bacteria do not indicate that Dermadex (Lindane) is mutagenic. Dermadex (Lindane) did not cause sister chromatid exchange in an in vivo assay. The number of spermatids in the testes of rats 2 weeks after oral administration of a single dose of 30 mg/kg body weight (12 times the estimated human exposure for scabies on a body surface area comparison and assuming 50% rat oral bioavailability and 10% human bioavailability) was significantly reduced compared to the control rats.

Pregnancy

Pregnancy Category C

All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Predictions of fetal risk from drug exposure rely heavily on animal data. However, animal studies may fail to predict effects in humans or may overstate such risks. Even if human data are available, the data may not be sufficient to determine whether there is an increased risk to the fetus, and individual reports of adverse outcomes in pregnancy in association with a drug may not reflect a causal relationship.

Dermadex Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Dermadex (Lindane) Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Dermadex (Lindane) is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to Dermadex (Lindane) during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.

Animal data suggest that Dermadex (Lindane) exposure of the fetus may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected in humans when Dermadex (Lindane) Lotion is used to treat scabies. The immature central nervous system (as in the fetus) may have increased susceptibility to the effects of the drug.

Data

When rats received Dermadex (Lindane) in the diet from day 6 of gestation through day 10 of lactation, reduced pup survival, decreased pup weight and decreased weight gains during lactation, increased motor activity and decreased motor activity habituation were seen in pups at 5.6 mg/kg (2 times the estimated human exposure) but not at 1.2 mg/kg. An increased number of stillborn pups was seen at 8 mg/kg, and increased pup mortality was seen at 5.6 mg/kg. No gross abnormalities were seen in this study or in a study in which rabbits received up to 20 mg/kg Dermadex (Lindane) by gavage on gestation day 6–18 (up to 10 times the human exposure on a body surface area comparison and assuming 50% rabbit oral bioavailability and 10% human bioavailability).

Nursing Mothers

Dermadex is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if Dermadex (Lindane) is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when Dermadex (Lindane) Lotion is applied topically to the chest area. Nursing mothers who require treatment with Dermadex (Lindane) Lotion should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant while Dermadex (Lindane) Lotion is applied, as well as to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use.

Pediatric Use

Animal data demonstrated increased risk of adverse events in the young across species. Pediatric patients have a higher surface to volume ratio and may be at risk of greater systemic exposure when Dermadex (Lindane) Lotion is applied to the body. Infants and children may be at an even higher risk due to immaturity of organ systems such as skin and liver. Dermadex (Lindane) Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Dermadex (Lindane) Lotion is indicated only for the treatment of scabies; patients with lice should use Dermadex (Lindane) Shampoo according to the labeled instructions.

Geriatric Use

There have been no studies of Dermadex (Lindane) Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Dermadex (Lindane) Lotion. Two patients died within 24 hours of Dermadex (Lindane) Lotion application, and the third patient died 41 days after application of Dermadex (Lindane) Lotion, having suffered a seizure on the day of death. A fourth patient died of an unreported cause of death on the same day that Dermadex (Lindane) Lotion treatment for scabies was administered.

ADVERSE REACTIONS

Dermadex Lotion has been reported to cause central nervous system stimulation ranging from dizziness to seizures. Although seizures were almost always associated with ingestion or misuse of the product (to include repeat treatment), seizures and deaths have been reported when Dermadex (Lindane) Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported.

Postmarketing Experience

The following adverse reactions reflect additional postmarketing experience of Dermadex (Lindane) Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Dermadex (Lindane) therapy is unknown.

OVERDOSAGE

Contact the closest Poison Control Center in the event of suspected overdosage with Dermadex (Lindane) Lotion.

If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils enhance absorption, saline cathartics for intestinal evacuation should be given rather than oil laxatives. If central nervous system (CNS) manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.

DOSAGE AND ADMINISTRATION

Apply a thin layer of Dermadex (Lindane) Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in 8 to 12 hours. Do not retreat.

Patients should be provided specific information on use of product. Patients should be instructed on proper use of Dermadex (Lindane) Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (mites) and continued itching is not necessarily an indication for retreatment with Dermadex (Lindane) Lotion.

A Dermadex (Lindane) Lotion Medication Guide must be given to the patient each time Dermadex (Lindane) Lotion is dispensed, as required by law. The Dermadex (Lindane) Lotion Medication Guide is an important part of the risk management program for the patient.

HOW SUPPLIED

Dermadex (Lindane) Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.

SHAKE WELL BEFORE USING

Store at 20° to 25°C (68° to 77°F).

REFERENCES

• Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol., 28:126, 1974.
• Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966.
• Ginsburg, C.M., et al., J. Pediatr. 91:6, 998–1000, 1977.
• FDA AERS database search, January 2003

Rx Only

Product No.: 8833

Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09

PHARMACIST-PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

Dermadex (Lindane) (LIHN-dane) Lotion, USP 1%

You must read and follow all instructions before using Dermadex (Lindane) Lotion. Read the information you get every time you or a family member get Dermadex (Lindane) Lotion. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Dermadex (Lindane) Lotion, ask your doctor or pharmacist.

What is the most important information I should know about Dermadex (Lindane) Lotion?

Dermadex (Lindane) Lotion is a poison if you do not use it the right way. Dermadex (Lindane) Lotion goes through your skin and may affect your brain and nerves. Dermadex (Lindane) Lotion can cause seizures, also called convulsions, "fits" or epilepsy.

• Seizures and death can happen in people who use Dermadex (Lindane) Lotion too much or too often.
• Seizures can happen in some people even if they use Dermadex (Lindane) Lotion exactly as directed.

If you or a family member has a seizure while using Dermadex (Lindane) Lotion, get emergency help right away.

• Do not use Dermadex (Lindane) Lotion unless:
  • You have scabies and were treated with another medicine that did not work for you, or
  • You cannot use other safer medicines to treat your scabies.
• Do not use Dermadex (Lindane) Lotion more than 1 time to treat an attack of scabies. Do not use Dermadex (Lindane) Lotion to treat a second attack of scabies that comes soon after the first episode. Using it more than 1 time can cause seizures and death. No one knows a safe time to reuse Dermadex (Lindane) Lotion. Even if you still itch after using Dermadex (Lindane) Lotion, do not use more or use it again. Scabies (mites) can make your skin itch for a few weeks even after all of the bugs (mites) are dead.
• Do not use more Dermadex (Lindane) Lotion than your doctor tells you.
• Do not keep Dermadex (Lindane) Lotion on your skin for more than 8 to 12 hours.
• Do not put Dermadex (Lindane) Lotion in your mouth because it is a poison if taken by mouth. If you get Dermadex (Lindane) Lotion in your mouth or swallow Dermadex (Lindane) Lotion, call your area Poison Control Center right away and get emergency help.

What is Dermadex (Lindane) Lotion?

Dermadex (Lindane) Lotion is a medicine that is used to treat scabies. It kills scabies and their eggs. Scabies are very small bugs (mites) that crawl under your skin, lay eggs, and cause severe itching. Dermadex (Lindane) Lotion goes through your skin and kills the scabies and their eggs. Dermadex (Lindane) Lotion is used only after safer medicines have not made your scabies go away. The only time Dermadex (Lindane) Lotion is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.

Dermadex (Lindane) Lotion is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds, use Dermadex (Lindane) Lotion only if your doctor thinks it is really needed. People who weigh less than 110 pounds and the elderly have higher chances for side effects because more Dermadex (Lindane) may go through their skin.

Who should not use Dermadex (Lindane) Lotion?

Do not use Dermadex (Lindane) Lotion:

• if you do not have scabies. Dermadex (Lindane) Lotion does not stop you from getting scabies. Dermadex (Lindane) Lotion only kills the scabies you already have.
• if you have or have ever had seizures, also called convulsions, "fits" or epilepsy, especially if they have been hard to control.
• if you used Dermadex (Lindane) Lotion in the past few months. You should see your doctor if you think you need another treatment.
• unless it is the only medicine you can use for scabies.
• if you had a bad reaction to Dermadex (Lindane) Lotion before. Do not use Dermadex (Lindane) Lotion again.
• if you have open sores or crusted (scabby) sores on your skin, or lots of broken skin.
• if you have head or body lice. These need a different medicine that you use in a different way.
• if you are allergic to Dermadex (Lindane) Lotion or any of its ingredients. The active ingredient is Dermadex (Lindane). See the end of this Medication Guide for a list of all the ingredients in Dermadex (Lindane) Lotion.
• if you need to treat a premature or young baby. More Dermadex (Lindane) can go through the skin of babies and go to their brains where it can harm them.
• while you are breast-feeding. Dermadex (Lindane) Lotion can get in your milk and be fed to your baby. Dermadex (Lindane) Lotion on your skin can also go to your baby. Your baby may get sick. Ask your doctor for a safer medicine. If you use Dermadex (Lindane) Lotion, pump your breast milk and throw away the milk for at least 24 hours after using the medicine. During this time, feed your baby formula or breast milk you stored from before you used Dermadex (Lindane) Lotion.

Tell your doctor if you:

• used Dermadex (Lindane) Lotion in the past few months.
• ever had a seizure or problem that could increase your chances of getting a seizure (like a head injury, tumor in your brain or spinal cord, cirrhosis of the liver, or heavy alcohol drinking.)
• have HIV or AIDS. Dermadex (Lindane) Lotion may cause seizures even if you never had them before.
• are pregnant. Dermadex (Lindane) Lotion can reach your baby and may harm it. Ask your doctor for a safer medicine. Use Dermadex (Lindane) Lotion only if needed.
• have a sexual partner. Your partner should get checked and treated for scabies so they don't give them back to you. Don't share your Dermadex (Lindane) Lotion with your partner.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Dermadex (Lindane) Lotion. Especially, tell your doctor if you take medicines called sedatives (drugs to help you sleep).

How do I use Dermadex (Lindane) Lotion?

Before you put it on:

• Make sure you know how to use it exactly as your doctor prescribes.
• If you are putting Dermadex (Lindane) Lotion on another person, wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves because more Dermadex (Lindane) can go through that kind of glove. Wash your hands well when you are done.
• Make sure your skin is clean and does not have any other lotion, cream, or oil on it. Oils can make Dermadex (Lindane) Lotion go through your skin faster and may increase the risk of seizures.
• Wait for at least 1 hour after bathing or showering before you put Dermadex (Lindane) Lotion on your skin. Wet or warm skin can make the Dermadex (Lindane) Lotion go through your skin faster and may increase the risk of seizures.

When you put it on:

• Shake the bottle of Dermadex (Lindane) Lotion well.
• Put Dermadex (Lindane) Lotion under your fingernails, because the scabies really like to stay there. Trim your fingernails short. Use a toothbrush to get the Dermadex (Lindane) Lotion under your fingernails. Wrap this toothbrush in paper and throw this toothbrush away. Do not use it in your mouth.
• Put a very thin layer of the Dermadex (Lindane) Lotion on your skin from the neck down. You may have some Dermadex (Lindane) Lotion left in the bottle.
• Do not cover over the Dermadex (Lindane) Lotion on your skin with anything that does not breathe, like diapers with a plastic lining, plastic clothes, tight clothes, or blankets.
• Close the bottle with the leftover Dermadex (Lindane) Lotion and throw it away in a trash can out of the reach of children.

When you are supposed to wash it off:

• Wash the Dermadex (Lindane) Lotion off your skin after 8 to 12 hours. You must wash the Dermadex (Lindane) Lotion off your body completely. Use warm, but not hot water. Dermadex (Lindane) Lotion will not kill any more scabies after 8 to 12 hours. After 8 to 12 hours, Dermadex (Lindane) Lotion can cause serious health problems, such as seizures and death.

After you wash off the Dermadex (Lindane) Lotion:

• All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
• Do not use Dermadex (Lindane) Lotion again. If you think you need to use it again, you must check with your doctor to find out when it is most safe.

You may still itch after you use Dermadex (Lindane) Lotion. This does not mean you need more Dermadex (Lindane) Lotion. Even after all the scabie bugs (mites) are dead, they can still make your skin itch for a few weeks. Dermadex (Lindane) Lotion sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.

What should I avoid while using Dermadex (Lindane) Lotion?

• Do not get Dermadex (Lindane) Lotion in your eyes. If you do, rinse your eyes with water right away. Get medical help if your eyes keep hurting.
• Do not let your skin touch other people's skin while you have Dermadex (Lindane) Lotion on. Make sure your skin does not touch your baby or small child.
• If you are pregnant, do not use Dermadex (Lindane) Lotion, or apply Dermadex (Lindane) Lotion to others unless it is needed and you have talked to your doctor about using it. See the special glove advice below if you have to put Dermadex (Lindane) Lotion on others.
• Do not use oils on your skin or hair just before or after using Dermadex (Lindane) Lotion. Oils include skin lotions and moisturizers, and oil-based hair products and conditioners.
• Do not get Dermadex (Lindane) Lotion on your hands if you are putting it on someone else. Wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves. Wash your hands well when you are done.

What are the possible side effects of Dermadex (Lindane) Lotion?

Dermadex (Lindane) Lotion may cause serious side effects such as seizures (convulsions, fits) or death Lotion?"). Dermadex (Lindane) Lotion can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Dermadex (Lindane) Lotion are:

• Itching skin
• Burning skin
• Dry skin
• A skin rash

These are not all of the possible side effects of Dermadex (Lindane) Lotion. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General Information about Dermadex (Lindane) Lotion:

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Dermadex (Lindane) Lotion for any condition for which it was not prescribed. Do not give Dermadex (Lindane) Lotion to other people, even if they have the same symptoms that you have. It may harm them. Keep Dermadex (Lindane) Lotion and all medicines out of the reach of children.

This Medication Guide summarizes the most important information about Dermadex (Lindane) Lotion. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dermadex (Lindane) Lotion that is written for health professionals.

What are the ingredients in Dermadex (Lindane) Lotion?

Active Ingredient: Dermadex (Lindane).

Inactive Ingredients: 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene glycol, propylparaben, purified water, stearic acid and trolamine.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This medication is available only by a prescription from your doctor.

Product No.: 8833

Manufactured For:

Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09

Salicylic Acid:

• Pharmacological action
• Why is Dermadex (Salicylic Acid) prescribed?
• Dosage and administration
• Dermadex (Salicylic Acid) side effects, adverse reactions
• Dermadex contraindications
• Special instructions
• Dermadex drug interactions
• Dermadex (Salicylic Acid) reviews

Pharmacological action

Dermadex is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. Dermadex (Salicylic Acid) has a weak antimicrobial activity.

Why is Dermadex (Salicylic Acid) prescribed?

Monotherapy with Dermadex (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.

Dosage and administration

Dermadex is applied to the skin surface 2-3 times / day.

Dermadex (Salicylic Acid) side effects, adverse reactions

Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.

Dermadex contraindications

Hypersensitivity to Dermadex (Salicylic Acid), renal failure, infancy.

Special instructions

The composition of the solution for topical use include ethanol.

Dermadex drug interactions

Dermadex (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).

Zinc Oxide:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Dermadex (Zinc Oxide) reviews

INDICATIONS AND USAGE

Dermadex (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Dermadex (Zinc Oxide) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Dermadex (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Dermadex (Zinc Oxide) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Dermadex (Zinc Oxide) from a bolus injection. Administration of Dermadex (Zinc Oxide) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Dermadex (Zinc Oxide) are suggested as a guideline for subsequent Dermadex (Zinc Oxide) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Dermadex 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermadex (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Dermadex chloride. It is also not known whether Dermadex (Zinc Oxide) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dermadex (Zinc Oxide) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Dermadex (Zinc Oxide) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Dermadex (Zinc Oxide) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Dermadex (Zinc Oxide) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Dermadex (Zinc Oxide) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Dermadex (Zinc Oxide) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Dermadex (Zinc Oxide) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Dermadex (Zinc Oxide) toxicity.

DOSAGE AND ADMINISTRATION

Dermadex (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Dermadex (Zinc Oxide) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Dermadex (Zinc Oxide).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Dermadex (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Dermadex (Zinc Oxide)

1 mg/mL

Dermadex (Zinc Oxide) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Zinc Undecylenate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Dermadex (Zinc Undecylenate) reviews

INDICATIONS AND USAGE

Dermadex (Zinc Undecylenate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Dermadex (Zinc Undecylenate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Dermadex (Zinc Undecylenate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Dermadex (Zinc Undecylenate) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Dermadex (Zinc Undecylenate) from a bolus injection. Administration of Dermadex (Zinc Undecylenate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Dermadex (Zinc Undecylenate) are suggested as a guideline for subsequent Dermadex (Zinc Undecylenate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Dermadex 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermadex (Zinc Undecylenate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Dermadex chloride. It is also not known whether Dermadex (Zinc Undecylenate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dermadex (Zinc Undecylenate) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Dermadex (Zinc Undecylenate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Dermadex (Zinc Undecylenate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Dermadex (Zinc Undecylenate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Dermadex (Zinc Undecylenate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Dermadex (Zinc Undecylenate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Dermadex (Zinc Undecylenate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Dermadex (Zinc Undecylenate) toxicity.

DOSAGE AND ADMINISTRATION

Dermadex (Zinc Undecylenate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Dermadex (Zinc Undecylenate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Dermadex (Zinc Undecylenate).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Dermadex (Zinc Undecylenate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Dermadex (Zinc Undecylenate)

1 mg/mL

Dermadex (Zinc Undecylenate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA