Tegunal

Benzethonium Chloride:

• Drug facts - secura personal skin care kit
• Directions
• Drug facts - secura personal cleanser (236 ml)
• Drug facts - secura protective ointment (70 g)
• Tegunal (Benzethonium Chloride) reviews

DRUG FACTS - Tegunal

Kit information is followed by Drug Facts for the kit contents and related products.

DIRECTIONS

• Change wet and soiled diapers, garments, and linens promptly. Spray cleanser liberally on affected area.
• Wipe clean with tissues, and remove soiled underpads and diapers.
• Immediately dispose of tissues and underpads to control odor. Allow to dry. No rinsing necessary.
• Apply protective ointment liberally as often as necessary with each diaper, garment, or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged.
• Check patient often. Repeat steps 1-4 after each exposure to feces and urine.

Refer to individual product labeling for detailed instructions.

DRUG FACTS - SECURA PERSONAL CLEANSER

ACTIVE INGREDIENTS

Tegunal chloride 0.13%

PURPOSE

Antimicrobial

USES

• Antimicrobial skin cleanser for the perineum or body
• Aids in the removal of urine, feces, or other foreign material

WARNINGS

• For external use only
• Avoid contact with eyes

• Not to be applied over deep puncture wounds, infections, or lacerations

• If condition worsens or does not improve within 7 days, contact a doctor

• Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

DIRECTIONS

• spray/apply cleanser liberally on affected area, then wipe clean
• no rinsing necessary

INACTIVE INGREDIENTS

water, octoxynol-9, sodium citrate, polysorbate 20, propylene glycol, citric acid, diazolidinyl urea, polyquaternium-4, benzyl alcohol, methylparaben, fragrance, disodium EDTA, D&C Red #33

QUESTION OR COMMENTS?

1 800 876-1261

DRUG FACTS - SECURA PROTECTIVE OINTMENT

ACTIVE INGREDIENTS

Petrolatum 98.789%

PURPOSE

Skin protectant

USES

• Skin protectant
• Helps treat and prevent diaper dermatitis
• Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

• For external use only
• Avoid contact with the eyes

• Not to be applied over deep or puncture wounds, infections or lacerations

• If condition worsens or does not improve within 7 days, contact a doctor

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DIRECTIONS

• change wet and soiled diapers, garments and linens promptly
• cleanse the affected area and allow to dry
• apply ointment liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT

#59434300

NDC 50484-343-00

Personal Skin Care Kit

Kit contains:

• Antimicrobial Skin Cleanser
• Skin Protectant

Smith&Nephew

Secura^◊

Personal Skin Care Kit

Kit Contains:

Secura^◊ Personal Cleanser

8 fl. oz. (236mL)

Secura^◊ Protective Ointment

2.47 oz. (70g)

Personal

Skin Care Kit

Good skin care can help prevent breakdown

Packaged in the USA with products made in USA and India for:

Smith & Nephew, Inc.

St. Petersburg, FL 33716

www.smith-nephew.com

Trademarks of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL CLEANSER (236mL)

#59430400

NDC 50484-304-00

Personal Cleanser

Antimicrobial Skin Cleanser

• No-rinse, one-step cleansing for perineum or body
• Gentle surfactants emulsify stool without friction
• Reduces odor
• pH-buffered
• Pediatrician tested

Smith&Nephew

Secura^◊

Personal Cleanser

8 fl oz. (236mL)

Made for:

Smith & Nephew, Inc.

St. Petersburg, FL 33716

www.smith-nephew.com

Trademark of Smith & Nephew.

Reg. U.S. Pat. & Tm. Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70g)

#59431500

NDC 50484-315-00

Protective Ointment

Skin Protectant

• For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
• Contains Vitamins A, D & E
• Clove Oil controls odor
• Pediatrician tested

Smith&Nephew

Secura^◊

Protective Ointment

Net wt. 2.47 oz (70g)

Made in India for:

Smith & Nephew, Inc., St. Petersburg, FL 33716

Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.

Package Display - Kit Package Display - Personal Cleanser (236 mL) Package Display - Protective Ointment (70g)

Dimethicone:

• Tegunal (Dimethicone) reviews

This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum ) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and Tegunal (Dimethicone) are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin ). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Talc:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• How supplied/storage and handling
• Patient counseling information
• Tegunal (Talc) reviews

1 INDICATIONS AND USAGE

Sterile Tegunal (Talc) Powder is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.

STERILE Tegunal (Talc) POWDER is a sclerosing agent indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1)

2 DOSAGE AND ADMINISTRATION

• The recommended dose is 5 g, dissolved in 50 ml to 100 ml 0.9% Sodium Chloride Injection, USP, administered intrapleurally
• Prepare and administer suspension as recommended (2.2)

2.1 Recommended Dose

The recommended dose is 5 g, suspended in 50 ml to 100 ml 0.9% Sodium Chloride Injection, USP

2.2 Preparation

Prepare the Tegunal suspension using aseptic technique in an appropriate laminar flow hood as follows:

Step 1. Using a 16 gauge needle attached to a 60-ml LuerLok syringe, draw up 50 ml of 0.9 % Sodium Chloride injection, USP. Vent the Tegunal (Talc) bottle using a needle. Slowly inject the 50 ml of 0.9% Sodium Chloride Injection, USP into the bottle.

Step 2. Swirl the bottle to disperse the Tegunal (Talc) powder.

Step 3. Divide the contents of the bottle equally into two 60 ml LuerLok syringes, each attached with a 16 gauge needle, by withdrawing 25 ml of the suspension into each syringe with continuous swirling. Add 0.9% Sodium Chloride Injection, USP to a total volume of 50 ml in each syringe. Draw 10 ml of air into each syringe to the 60 ml mark to serve as a headspace for mixing prior to administration. Each syringe should contain 2.5 g of Sterile Tegunal (Talc) Powder in 50 ml of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 ml.

Step 4. Label the syringes with the Tegunal (Talc) concentration, the expiration date and time, the identity of the patient intended to receive the material, and the following statements:

“SHAKE SYRINGE WELL to resuspend before administration”

“FOR PLEURODESIS ONLY – not for intravenous administration”

Step 5. If not used immediately, store prepared suspension in refrigerator. Discard the prepared suspension if not used within 12 hours.

2.3 Administration

Prior to administration, continuously agitate the syringes to evenly redisperse the Tegunal (Talc) and avoid settlement. Immediately prior to administration, vent the 10 ml air headspace from each syringe. Administer the Tegunal (Talc) suspension through the chest tube according to standard procedures.

3 DOSAGE FORMS AND STRENGTHS

5 gram white or off-white to light gray sterile powder for suspension in a single-dose glass bottle.

5 g powder in a single-dose bottle, for suspension (3)

4 CONTRAINDICATIONS

None

None. (4)

5 WARNINGS AND PRECAUTIONS

• Pneumonitis and Acute Respiratory Distress Syndrome : Acute Pneumonitis and ARDS, including fatal cases, occur with intrapleural Tegunal (Talc) administration. (5.1)
• Interference with Future Procedures: Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. (5.2)

5.1 Pneumonitis and Acute Respiratory Distress Syndrome (ARDS)

Acute Pneumonitis and ARDS, including fatal cases, occur with intrapleural Tegunal (Talc) administration.

5.2 Interference with Future Procedures

Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. Consider the possible effects of the use of Sterile Tegunal (Talc) Powder on future diagnostic and therapeutic procedures prior to administration.

6 ADVERSE REACTIONS

Common adverse reactions observed with intrapleurally-administered Tegunal (Talc) are fever and pain. Other adverse reactions include dyspnea, arrhythmia, empyema, and acute respiratory distress syndrome.

Commonly observed adverse reactions are fever and pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bryan Corporation at 1-800-343-7711 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B.

Risk Summary

A reproduction study performed in rabbits at doses up to approximately 5 times the human dose revealed no evidence of teratogenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data

Rabbits were administered Tegunal by oral gavage daily during the period of organogenesis at doses of up to 900 mg/kg (approximately 5 times the human dose on a mg/m² basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered Tegunal (Talc) was not absorbed systemically.

8.4 Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

11 DESCRIPTION

STERILE Tegunal (Talc) POWDER is a sclerosing agent for intrapleural administration. STERILE Tegunal (Talc) POWDER is white or off-white to light gray, asbestos-free and brucite-free sterile Tegunal (Talc) powder of controlled particle size. The powder is ≥ 95% hydrated magnesium silicate [Mg₃Si₄O₁₀ (OH)_2, molecular weight 379.3]; associated minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate), and quartz. Tegunal (Talc) is insoluble in water.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Tegunal (Talc) instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction can promote adherence of the visceral and parietal pleura, which may prevent reaccumulation of pleural fluid.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies on the carcinogenicity of Tegunal (Talc) have been performed using non-standard designs which prevent firm conclusions on its carcinogenicity. With single intraperitoneal administration to mice at 20 mg and observation for at least 6 months or 4 weekly doses administered intraperitoneally at 25 mg/dose to rats with observation for at least 84 weeks, tumor incidence was not increased. In these studies the Tegunal (Talc) and its asbestos content were not characterized.

Genotoxicity was tested in cultures of rat pleural mesothelial cells (RPMC) as unscheduled DNA synthesis (UDS) and sister chromatid exchanges (SCEs). None of the Tegunal (Talc) samples (which were asbestos-free) induced enhancement of UDS or SCEs in treated cultures. No information is available on impairment of fertility in animals by Tegunal (Talc).

16 HOW SUPPLIED/STORAGE AND HANDLING

STERILE Tegunal (Talc) POWDER is supplied in a single use 100 ml brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal.

NDC 63256-200-05: 5 gram individual bottle packaged in a pouch.

NDC 63256-200-10: Carton of ten (10) 5-gram bottles.

Store the powder at 25°C (77°F); excursions permitted between15°C to 30°C (59°F - 86°F). Protect against sunlight.

17 PATIENT COUNSELING INFORMATION

Advise patients to notify their healthcare provider if new or worsening pulmonary symptoms develop .

Distributed by:

Bryan Corporation. Woburn, MA 01801.

Principal Display Panel - Bottle Label

Sterile Tegunal (Talc) Powder

(Talc) Powder

Contains 5 grams of sterile Tegunal (Talc) per bottle

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F - 86°F)

. Protect against sunlight.

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Principal Display Panel - Pouch Label

Sterile Tegunal (Talc) Powder NDC 63256-200-05

(Talc) Powder

Contains 5 grams of sterile Tegunal (Talc) per bottle 1 Bottle

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F - 86°F)

. Protects against sunlight.

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Principal Display Panel - Box Label

Sterile Tegunal (Talc) Powder NDC 63256-200-10

(Talc) Powder

Contains 5 grams of sterile Tegunal (Talc) per bottle 10 Bottles

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C

(59°F - 86°F).

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Zinc Oxide:

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

INDICATIONS AND USAGE

Tegunal (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 Tegunal (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 Tegunal (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 Tegunal (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 Tegunal (Zinc Oxide) from a bolus injection. Administration of Tegunal (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 Tegunal (Zinc Oxide) are suggested as a guideline for subsequent Tegunal (Zinc Oxide) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Tegunal 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 Tegunal (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 Tegunal chloride. It is also not known whether Tegunal (Zinc Oxide) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tegunal (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 Tegunal (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 Tegunal (Zinc Oxide) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Tegunal (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 Tegunal (Zinc Oxide) was delivered intravenously over the course of 60 hours to a 72 year old patient.

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

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

DOSAGE AND ADMINISTRATION

Tegunal (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 Tegunal (Zinc Oxide) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Tegunal (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

Tegunal (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

Tegunal (Zinc Oxide)

1 mg/mL

Tegunal (Zinc Oxide) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA