ATHLETES FOOT- terbinafine hydrochloride cream 
Chain Drug Marketing Association, Inc.

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Athlete's Foot Cream

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

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.

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

Directions

Other information

Inactive ingredients

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

Questions?

Call 1-800-935-2362

DISTRIBUTED BY QUALITY CHOICE
43157 WEST NINE MILE ROAD, NOVI, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

QC
QUALITY
CHOICE
®

Athlete's Foot Cream

Terbinafine Hydrochloride Cream 1%

Antifungal

NET WT 1/2 OZ (15 g )

Principal Display Panel - 15 g Tube Carton
ATHLETES FOOT 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-364-121 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(63868-364)

Revised: 12/2012
Document Id: f7c65393-e192-47eb-8272-9ab447c41ee1
Set id: 75808698-acfd-4727-a837-461465019e0e
Version: 1
Effective Time: 20121204
 
Chain Drug Marketing Association, Inc.