Zogbet-MG

Clobetasol:

• Zogbet-MG information
• Zogbet-MG indications
• Zogbet-MG warnings
• Zogbet-MG intake guidelines
• Zogbet-MG dosage
• Zogbet-MG overdose
• Zogbet-MG missed dose
• Zogbet-MG side effects
• Zogbet-MG drug reactions
• Zogbet-MG (Clobetasol) reviews

Zogbet-MG information

Zogbet-MG (Clobetasol) (also known as Clobevate, Cormax, Cormax Scalp Application, Embeline, Olux, and Temovate) is a strong corticosteroid, used to treat a variety of skin conditions such as dermatitis, allergies, rashes and eczema.

Zogbet-MG indications

Zogbet-MG (Clobetasol) is a popular medicine that is generally prescribed in the treatment of the patients with skin diseases in order to reduce the itching, redness and swelling of the affected parts of the body. Zogbet-MG (Clobetasol) is meant only for external use. Patients should not allow the medication to get into their eyes, nose and mouth. Patients should also avoid putting dressings, other skin medications or bandages on the area which is treated with Zogbet-MG (Clobetasol) Pharmaniaga.

Zogbet-MG warnings

Before beginning the treatment with Zogbet-MG (Clobetasol) the patients should inform their doctor or personal healthcare provider if they are allergic to any of this drug's components or to any other corticosteroids such as Prednisone or hydrocortisone. Patients should also tell the doctor if they have other allergies. Before using Zogbet-MG (Clobetasol) patients must tell their PD about their medical history, especially if they have immune system problems, poor blood circulation or other skin conditions such as dermatitis. In very rare cases this medicine might be absorbed into the bloodstream and this condition will require treatment also based on corticosteroids. This may happen in children who are using it or in the case of individuals who have been using it for long periods of time. Pregnant women should not use Zogbet-MG (Clobetasol) Pharmaniaga, unless it is clearly needed; however, they should discuss with their personal healthcare provider the benefits and risks of such a treatment.

Zogbet-MG intake guidelines

Patients should use Zogbet-MG (Clobetasol) only on the skin and not on the groin, underarms, face, unless their doctor or personal healthcare provider advises them to do so. You should wash and dry your hands very well and thoroughly clean the affected area before applying Zogbet-MG (Clobetasol) Pharmaniaga. This medicine should be applied in a thin film to the affected area and then rubbed. This process should be done by patients two times a day, except the cases when the doctor has prescribed them other instructions. When the patients must apply this medicine near the eyes, they should be extra careful not to put it in their eyes because this can lead to a medical condition known as glaucoma.

Zogbet-MG dosage

Zogbet-MG (Clobetasol) should be applied directly on the affected skin areas at least twice a day. The treatment should not last longer than four weeks, as this medicine contains a very strong topical corticosteroid. Usually the dose should not be more than 50g a week.

You should not use a medicine which looks discolored or that contains any sort of particle. Do not stop your treatment with Zogbet-MG (Clobetasol) without your physician's approval, even if you feel that your condition has not improved at all. If you feel that your treatment with this medicine is not working properly, you should alert your personal health care provider.

Zogbet-MG overdose

In most of the cases that involve an overdose of Zogbet-MG (Clobetasol) Pharmaniaga, the medicine is absorbed in an abnormally high amount in the patient's blood stream; this can lead to systemic effects. The systemic absorption usually cases reversible adrenal suppression which may eventually lead to an insufficiency of corticosteroids in the organism. In other cases the patients may experience symptoms of Cushing's syndrome, glucosuria and even hyperglycemia which are also due to the systemic absorption.

Zogbet-MG missed dose

It is important to try to take each of your scheduled doses of Zogbet-MG (Clobetasol) at their due time. However, if you happen to miss taking one of your prescribed doses of this product you should use it as soon as you recall. If it is already time for another dose, we advise you to forget about the one that you have missed and to proceed with your regular dosing schedule. Do not apply double doses of Zogbet-MG (Clobetasol) without your personal physician's approval.

Zogbet-MG side effects

The most common side effects that patients who are under treatment with Zogbet-MG (Clobetasol) may experience are the following: burning, stinging, dryness, redness, itching, and so on. These side effects usually appear when the product is applied to the skin for the first time, but they should pass in a few days; in case these side effects do not go away the patients should contact their pharmacist or personal healthcare provider.

Individuals should alert their doctor or health care specialist if they develop any of the following side effects: stretch marks, acne, hair bumps (also known as follicullitis), skin thinning, skin discoloration, extreme hair growth and unwanted hair growth. Patients should also inform their doctor if the redness, irritation and swelling do not improve. Serious allergic reactions are very rare in patients who are using Zogbet-MG (Clobetasol) Pharmaniaga, but in case the patients experience rash, swelling, itching, breathing problems, severe dizziness, they should inform their physician as quickly as they can. This is not a complete list with the side effects that the intake of this medicine can lead to; this is why it is very important to discuss with your doctor in the case in which you develop other symptoms than those listed above.

Zogbet-MG drug reactions

Generally it is improbable for Zogbet-MG (Clobetasol) to interact with other drugs. However, it is well known that many drugs harmfully interact among each other and this is why it is very important to inform your doctor about all the other medicines that you are taking during your therapy with this drug (including vitamins, minerals, over-the-counter medications or herbal products). It is also important to not start taking a new drug without consulting with your personal healthcare provider.

Miconazole:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Zogbet-MG (Miconazole) reviews

1 INDICATIONS AND USAGE

• Zogbet-MG Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. (1)
• Zogbet-MG (Miconazole) Ointment should not be used as a substitute for frequent diaper changes. (1)
• Zogbet-MG (Miconazole) Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1)

1.1 Indication

Zogbet-MG (Miconazole) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicansis not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.

Zogbet-MG (Miconazole) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.

Zogbet-MG (Miconazole) should not be used as a substitute for frequent diaper changes. Zogbet-MG (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

1.2 Limitations of Use

The safety and efficacy of Zogbet-MG (Miconazole) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

The safety and efficacy of Zogbet-MG (Miconazole) have not been evaluated in incontinent adult patients. Zogbet-MG (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

2 DOSAGE AND ADMINISTRATION

Zogbet-MG (Miconazole) is not for oral, ophthalmic, or intravaginal use.

Before applying Zogbet-MG (Miconazole), gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.

Apply Zogbet-MG (Miconazole) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of Zogbet-MG (Miconazole) when used for longer than 7 days is not known. Do not use Zogbet-MG (Miconazole) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

Gently apply a thin layer of Zogbet-MG (Miconazole) to the diaper area with the fingertips. Do not rub Zogbet-MG (Miconazole) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Zogbet-MG (Miconazole).

• Zogbet-MG (Miconazole) Ointment is for topical use only. Zogbet-MG (Miconazole) Ointment is not for oral, ophthalmic, or intravaginal use. (2)
• Zogbet-MG (Miconazole) Ointment should be applied as a thin layer to the affected area at each diaper change for 7 days. (2)
• Zogbet-MG (Miconazole) Ointment should be used as part of a treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2)

3 DOSAGE FORMS AND STRENGTHS

White ointment containing 0.25% Zogbet-MG (Miconazole) nitrate, 15% zinc oxide, and 81.35% white petrolatum.

• Ointment with 0.25% Zogbet-MG (Miconazole) nitrate, 15% zinc oxide, and 81.35% white petrolatum. (3)

4 CONTRAINDICATIONS

None

• None

5 WARNINGS AND PRECAUTIONS

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of Zogbet-MG (Miconazole) have not been evaluated in incontinent adult patients. Zogbet-MG (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

• If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5)

6 ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Zogbet-MG group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Zogbet-MG (Miconazole) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of Zogbet-MG (Miconazole).

GASTROINTESTINAL DISORDERS: vomiting

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: burning sensation, condition aggravated, inflammation, pain

INJURY, POISONING AND PROCEDURAL COMPLICATIONS: accidental exposure

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

7 DRUG INTERACTIONS

Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Zogbet-MG (Miconazole) intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Zogbet-MG (Miconazole) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Zogbet-MG in pregnant women. Therefore, Zogbet-MG (Miconazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Zogbet-MG (Miconazole) nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.

8.3 Nursing Mothers

Safety and efficacy of Zogbet-MG (Miconazole) have not been established in nursing mothers. It is not known if the active components of Zogbet-MG (Miconazole) may be present in milk.

8.4 Pediatric Use

Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.

Zogbet-MG should not be used to prevent diaper dermatitis.

The safety of Zogbet-MG (Miconazole) when used for longer than 7 days is not known. Do not use more than 7 days.

8.5 Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

11 DESCRIPTION

Zogbet-MG (Miconazole) contains the synthetic antifungal agent, Zogbet-MG (Miconazole) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.

The chemical name of Zogbet-MG (Miconazole) nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C₁₈H₁₄Cl₄N₂O-HNO₃ and molecular weight of 479.15. The structural formula of Zogbet-MG (Miconazole) nitrate is as follows:

The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.

The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula C_nH_2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.

Each gram of Zogbet-MG (Miconazole) contains 2.5 mg of Zogbet-MG (Miconazole) nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm^® 1001/B fragrance.¹

Zogbet-MG (Miconazole) is a smooth, uniform, white ointment.

Structural formula of Zogbet-MG (Miconazole) nitrate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The Zogbet-MG component of Zogbet-MG (Miconazole) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

12.2 Pharmacodynamics

The human pharmacodynamics of Zogbet-MG (Miconazole) is unknown.

12.3 Pharmacokinetics

The topical absorption of Zogbet-MG from Zogbet-MG (Miconazole) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of Zogbet-MG (Miconazole) were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of Zogbet-MG (Miconazole) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

12.4 Microbiology

The Zogbet-MG (Miconazole) nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of Zogbet-MG (Miconazole) nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 (see Clinical Studies (14)) does not appear to indicate that resistance to Zogbet-MG (Miconazole) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Zogbet-MG (Miconazole) nitrate against C. albicans in the setting of diaper dermatitis is unclear.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Zogbet-MG (Miconazole) in animals has not been evaluated.

Zogbet-MG (Miconazole) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Zogbet-MG (Miconazole) nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

14 CLINICAL STUDIES

Study 1 was a double-blind, multicenter study in which Zogbet-MG (Miconazole) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

Study results are shown in the following table.

Two additional studies provided supportive evidence of the clinical efficacy of Zogbet-MG (Miconazole) in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Zogbet-MG is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

50g (NDC 40076-002-50)

16.2 Storage Conditions

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients using Zogbet-MG (Miconazole) should be informed about the following information:

• Zogbet-MG (Miconazole) is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
• Zogbet-MG (Miconazole) should not be used as a substitute for frequent diaper changes.
• Zogbet-MG (Miconazole) should not be used to prevent diaper dermatitis.
• Zogbet-MG (Miconazole) should not be used long term.
• Zogbet-MG (Miconazole) should be used only as directed by the health care provider.
• Zogbet-MG (Miconazole) is for external use only. It is not for oral, ophthalmic, or intravaginal use.
• Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying Zogbet-MG (Miconazole).
• Gently apply Zogbet-MG (Miconazole) to the diaper area with the fingertips after each diaper change. Do not rub Zogbet-MG (Miconazole) into the skin as this may cause additional irritation.
• Thoroughly wash hands after applying Zogbet-MG (Miconazole).
• Treatment should be continued for 7 days, even if there is improvement. Do not use Zogbet-MG (Miconazole) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
• Zogbet-MG (Miconazole) should not be used on children for whom it is not prescribed.

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

Revised Oct 2013 VSN:3PI

FDA-Approved Patient Labeling

Zogbet-MG (Miconazole)^® (Vu-sion) Ointment

(0.25% Zogbet-MG (Miconazole) nitrate, 15% zinc oxide and 81.35% white petrolatum)

IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.

Read the Patient Information that comes with Zogbet-MG (Miconazole) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on Zogbet-MG (Miconazole), ask your health care provider, or pharmacist.

What is Zogbet-MG (Miconazole)?

Zogbet-MG (Miconazole) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. Zogbet-MG (Miconazole) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use Zogbet-MG (Miconazole), diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. Zogbet-MG (Miconazole) is not to be used to prevent diaper rash or to be used for more than 7 days.

Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use Zogbet-MG (Miconazole) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use Zogbet-MG (Miconazole)?

Zogbet-MG (Miconazole) is not for treatment of all cases of diaper rash. Zogbet-MG (Miconazole) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in Zogbet-MG (Miconazole) because most cases of diaper rash do not also have a yeast infection.

Do not use Zogbet-MG (Miconazole) on any other children or other family member.

Do not use Zogbet-MG (Miconazole) on your child’s diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in Zogbet-MG (Miconazole).

Do not use on infants less than 4 weeks of age.

Do not use in infants or children who do not have a normal immune system.

How should I use Zogbet-MG (Miconazole) on my child?

Zogbet-MG (Miconazole) is applied to the skin on your child’s diaper area at each diaper change for 7 days.

Apply Zogbet-MG (Miconazole) for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with Zogbet-MG (Miconazole). Zogbet-MG (Miconazole) should not be used for more than 7 days.

To apply Zogbet-MG (Miconazole):

• Gently, clean the skin on your child’s diaper area with warm ( not hot ) water. You may also use a very mild soap. Pat the area dry with a soft towel.
• Use your fingertips and gently apply a thin layer of Zogbet-MG (Miconazole) to your child’s diaper area at each diaper change. Do not rub Zogbet-MG (Miconazole) into your child’s skin. Rubbing the skin can cause more irritation.
• Wash your hands after applying Zogbet-MG (Miconazole) on your child.

Zogbet-MG (Miconazole) is for skin use only.

Call your child’s health care provider or poison control center right away if any Zogbet-MG (Miconazole) is swallowed. Call your child’s health care provider if Zogbet-MG (Miconazole) gets in the eye.

Keep out of reach of children.

What other steps will help diaper rash go away?

• Check your child’s diaper often. Change the diaper at the first sign of wetness.
• Clean your child’s diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm ( not hot )water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
• Keep the diaper area open to air when possible.
• Even if you use Zogbet-MG (Miconazole), diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

What are the possible side effects of Zogbet-MG (Miconazole)?

Zogbet-MG (Miconazole) may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.

How should I store Zogbet-MG (Miconazole)?

• Keep Zogbet-MG (Miconazole) out of the reach of children to avoid the risk of accidental ingestion.
• Store Zogbet-MG (Miconazole) at room temperature between 68°F to 77°F (20°C to 25°C).

General information about Zogbet-MG (Miconazole)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Zogbet-MG (Miconazole) for a condition for which it was not prescribed. Do not give Zogbet-MG (Miconazole) to other children or family members, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about Zogbet-MG (Miconazole). If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about Zogbet-MG (Miconazole) that is written for healthcare professionals.

Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.

What are the ingredients in Zogbet-MG (Miconazole)?

Active Ingredients: Zogbet-MG (Miconazole) nitrate, zinc oxide, and white petrolatum

Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm^® 1001/B fragrance

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: October 2013

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of

Prestium Pharma, Inc.

Revised Oct 2013

VSN:3PIL

Principal Display Panel

NDC 40076-002-50

Zogbet-MG (Miconazole)^®

(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)

Ointment

50 grams

R_x only

Principal Display Panel NDC 40076-002-50 Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only