SPL UNCLASSIFIED

Drug Facts

OTC - ACTIVE INGREDIENT

Terbinafine hydrochloride 1%

OTC - PURPOSE

Antifungal

INDICATIONS & USAGE

• 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

• 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.

• 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.

DOSAGE & ADMINISTRATION

• 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

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

STORAGE AND HANDLING

• 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 INGREDIENT

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

SPL UNCLASSIFIED

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Terbinafine Hydrochloride

GENERIC: Terbinafine Hydrochloride

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 61786-223-02

ACTIVE INGREDIENT(S):

• Terbinafine Hydrochloride 1g in 100g

INACTIVE INGREDIENT(S):

• benzyl alcohol
• sodium hydroxide
• sorbitan monostearate
• water
• polysorbate 60
• cetyl alcohol
• cetyl palmitate
• isopropyl myristate
• stearyl alcohol

COLOR: white

PACKAGING: 30 g in 1 TUBE

OUTER PACKAGING: 1 TUBE in 1 CARTON