Terbinafine Hydrochloride

Preferred Pharmaceuticals, Inc

Terbinafine Hydrochloride Cream 1% Antifungal Cream

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Terbinafine Hydrochloride Uses
• Warnings
  • Do not use
  • Stop use and ask a doctor if
• Directions
• Terbinafine Hydrochloride Other information
• Inactive ingredients
• How Supplied
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Terbinafine Hydrochloride Uses

• •cures most athlete's foot (tinea pedis)
• •cures most jock itch (tinea cruris) and ringworm (tinea corporis)
• •relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do not use

• •on nails or scalp
• •in or near the mouth or the eyes
• •for vaginal yeast infections

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

• •too much irritation occurs or gets worse.
• •side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

adults and children 12 years and older

use the tip of the cap to break the seal and open the tube

wash the affected skin with soap and water and dry completely before applying

for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.

on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.

for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.

wash hands after each use

children under 12 years: ask a doctor

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1 week between the toes 2 weeks on the bottom or sides of the foot

Terbinafine Hydrochloride Other information

• •do not use if seal on tube is broken or is not visible
• •store at controlled room temperature 20°-25°C (68°-77°F)
• •see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

How Supplied

Terbinafine Hydrochloride Cream 1% is available in 15gm tubes - 68788-9814-1

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled By Preferred Pharmaceuticals, Inc

PRINCIPAL DISPLAY PANEL

Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM Product Information Product Type Human otc drug label Item Code (Source) NDC:68788-9814(NDC:51672-2080) Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE Terbinafine 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CETYL ALCOHOL cetyl palmitate ISOPROPYL MYRISTATE POLYSORBATE 60 water SODIUM HYDROXIDE SORBITAN MONOSTEARATE stearyl alcohol Product Characteristics Color WHITE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-9814-1 15 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077511 2012-04-05