LOTRIMIN ULTRA- butenafine hydrochloride cream 
Bayer Healthcare LLC.

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Lotrimin Ultra ®

Drug Facts

Active Ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

Uses

Warnings

For external use only

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?

1-866-360-3266 or visit us at www.lotrimin.com

​LOTRIMIN ULTRA ®

BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL

NET WT 20g (0.70 OZ)

Lotrimin Ultra

LOTRIMIN ULTRA 
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X) BUTENAFINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETETH-23 (UNII: 495CTZ441V)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0082-11 in 1 CARTON12/20/2021
120 g in 1 TUBE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130712/20/2021
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 11/2023
Document Id: 0b61ea71-e588-bff5-e063-6394a90a2e50
Set id: d11dfdf6-9b36-03bc-e053-2995a90a0bc3
Version: 5
Effective Time: 20231130
 
Bayer Healthcare LLC.