LOTRIMIN ULTRA JOCK ITCH- butenafine hydrochloride cream 
Bayer Healthcare LLC.

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Lotrimin Ultra ®

Jock Itch

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

Distributed by Bayer HealthCare LLC, Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

LOTRIMIN ULTRA®

butenafine hydrochloride cream 1% ANTIFUNGAL NET WT 12g (0.42 OZ)

Lotrimin Ultra JI 4339

LOTRIMIN ULTRA  JOCK ITCH
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4339
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
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)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4339-11 in 1 CARTON02/22/2002
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11523-4339-21 in 1 CARTON02/22/2002
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11523-4339-31 in 1 CARTON09/26/2023
330 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130702/22/2002
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 9/2023
Document Id: 06444b26-dfe0-cb46-e063-6294a90adf2b
Set id: 9dfa08fb-0913-4326-b1eb-1425df6a2c82
Version: 7
Effective Time: 20230926
 
Bayer Healthcare LLC.