BUTENAFINE HYDROCHLORIDE- butenafine hydrochloride cream 
YYBA CORP

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Butenafine Hydrochloride

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 1-866-933-6337

Distributed by:
Wellspring
Airmont, NY 10952, U.S.A.

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Butenafine
Hydrochloride Cream 1%

Antifungal
NET WT 30 g (1 oz)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
BUTENAFINE HYDROCHLORIDE 
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-210
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)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-210-021 in 1 CARTON10/12/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20518110/12/2023
Labeler - YYBA CORP (006339772)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(73581-210)

Revised: 10/2023
Document Id: cc5f372c-2a7c-47f0-b324-d0cf2c363279
Set id: e650d8aa-c809-42ee-a1d9-a6321d5364f5
Version: 1
Effective Time: 20231018
 
YYBA CORP