ATHLETES FOOT- butenafine hydrochloride cream 
Taro Pharmaceuticals U.S.A., inc.

----------

Athlete's Foot Cream

Drug Facts

Active ingredient

Butenafine 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 irritation gets worse

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, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Questions?

Call 1-866-923-4914

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

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Clinically Proven to Cure Most Athlete's Foot between the Toes

Butenafine
Hydrochloride Cream 1%

Antifungal
NET WT 15 g (0.53 oz)

Principal Display Panel - 15 g Tube Carton
ATHLETES FOOT 
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Butenafine Hydrochloride (UNII: R8XA2029ZI) (Butenafine - UNII:91Y494NL0X) Butenafine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
cetyl alcohol (UNII: 936JST6JCN)  
glycerin (UNII: PDC6A3C0OX)  
ceteth-23 (UNII: 495CTZ441V)  
propylene glycol dicaprylate (UNII: 581437HWX2)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
stearic acid (UNII: 4ELV7Z65AP)  
trolamine (UNII: 9O3K93S3TK)  
petrolatum (UNII: 4T6H12BN9U)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2100-81 in 1 CARTON11/17/2017
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2100-11 in 1 CARTON11/17/2017
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:51672-2100-91 in 1 CARTON11/17/2017
324 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:51672-2100-21 in 1 CARTON11/17/2017
430 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20518111/17/2017
Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2100)

Revised: 11/2017
Document Id: 2c67420b-73a6-4382-bc58-fc031ac3e6af
Set id: 4b400be5-acaa-4a5f-b8ef-c0df8ad6175f
Version: 4
Effective Time: 20171120
 
Taro Pharmaceuticals U.S.A., inc.