MENTAX: Package Insert and Label Information (Page 2 of 2)

Teratogenic Effects

Subcutaneous doses of butenafine (dose levels up to 25 mg/kg/day administered during organogenesis) (equivalent to 0.5 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons) were not teratogenic in rats. In an oral embryofetal development study in rabbits (dose levels up to 400 mg butenafine HCl/kg/day administered during organogenesis) (equivalent to 16 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons), no treatment-related external, visceral, skeletal malformations or variations were observed.

In an oral peri- and post-natal developmental study in rats (dose levels up to 125 mg butenafine HCl/kg/day) (equivalent to 2.5 times the maximum recommended dose in humans for tinea versicolor based on body surface area comparisons), no treatment-related effects on postnatal survival, development of the F1 generation or their subsequent maturation and fertility were observed.

There are, however, no adequate and well-controlled studies that have been conducted with topically applied butenafine 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.

Nursing Mothers

It is not known if butenafine HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing Mentax® Cream, 1%, to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 12 years have not been studied since tinea versicolor is uncommon in patients below the age of 12 years.

ADVERSE REACTIONS

In controlled clinical trials, 9 (approximately 1%) of 815 patients treated with Mentax® Cream, 1%, reported adverse events related to the skin. These included burning/stinging, itching and worsening of the condition. No patient treated with Mentax® Cream, 1%, discontinued treatment due to an adverse event. In the vehicle-treated patients, 2 of 718 patients discontinued because of treatment site adverse events, one of which was severe burning/stinging and itching at the site of application.

In uncontrolled clinical trials, the most frequently reported adverse events in patients treated with Mentax® Cream, 1%, were: contact dermatitis, erythema, irritation, and itching, each occurring in less than 2% of patients.

In provocative testing in over 200 subjects, there was no evidence of allergic-contact sensitization for either cream or vehicle base for Mentax® Cream, 1%.

OVERDOSAGE

Overdosage of butenafine HCl in humans has not been reported to date.

DOSAGE AND ADMINISTRATION

Patients with tinea (pityriasis) versicolor should apply Mentax® Cream, 1%, once daily for two weeks. Sufficient Mentax® Cream should be applied to cover affected areas and immediately surrounding skin of patients with tinea versicolor. If a patient shows no clinical improvement after the treatment period, the diagnosis and therapy should be reviewed.

HOW SUPPLIED

Mentax® (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes:

15-gram tube (NDC 0378-6151-46)

30-gram tube (NDC 0378-6151-49)

STORE BETWEEN 5° and 30°C (41° and 86°F).

Keep this and all medications out of the reach of children.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 6/2018
029.8

MENTAX:R8

PRINCIPAL DISPLAY PANEL — 15 g

NDC 0378-6151-46

MENTAX®
(butenafine HCl) Cream 1%

For Topical Dermatologic Use Only — Not for Oral, Ophthalmic or Intravaginal Use

Each gram contains 10 mg of butenafine hydrochloride, purified water USP, propylene glycol
dicaprylate, glycerin USP, cetyl alcohol NF, glyceryl monostearate SE, white petrolatum USP, stearic acid
NF, polyoxyethylene (23) cetyl ether, benzyl alcohol NF, diethanolamine NF and sodium benzoate NF.

Usual Dosage: See accompanying package insert for full prescribing information.

For external use only.

Keep this and all medications out of the reach of children.

Store between 5° and 30°C (41° and 86°F).

See end flap for lot number and expiration date.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

559.8
MI:151:02:1C:R8

Mentax Cream 1% 15g Carton Label
(click image for full-size original)
MENTAX
butenafine hydrochloride cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTENAFINE HYDROCHLORIDE (BUTENAFINE) BUTENAFINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
GLYCERIN
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
PETROLATUM
STEARIC ACID
BENZYL ALCOHOL
DIETHANOLAMINE
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-6151-46 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0378-6151-46)
2 NDC:0378-6151-49 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (0378-6151-49)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020524 12/31/1996
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 06/2018 Mylan Pharmaceuticals Inc.

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