ATHLETES FOOT- terbinafine hydrochloride cream

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Terbinafine hydrochloride 1%
Purpose

Antifungal
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.

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

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
SPL UNCLASSIFIED SECTION

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99
PLEASANTON, CA 94566-0009
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Cures Most
Athlete's Foot

NDC: 21130-080-02

Compare to
Lamisil AT®
active ingredient*

Athlete's
Foot Cream

Terbinafine Hydrochloride
Cream 1% Antifungal Cream
- Relieves Itching & Burning
- Full Prescription Strength
NET WT 1.0 OZ (30 g)
SAFEWAY™

INGREDIENTS AND APPEARANCE

ATHLETES FOOT
terbinafine hydrochloride cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)	Terbinafine Hydrochloride	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
benzyl alcohol (UNII: LKG8494WBH)
cetyl alcohol (UNII: 936JST6JCN)
cetyl palmitate (UNII: 5ZA2S6B08X)
isopropyl myristate (UNII: 0RE8K4LNJS)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
sorbitan monostearate (UNII: NVZ4I0H58X)
stearyl alcohol (UNII: 2KR89I4H1Y)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077511	07/02/2007

Labeler - Safeway Inc. (009137209)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(21130-080)

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