LOTRIMIN ULTRA ANTIFUNGAL- butenafine hydrochloride cream 
Bayer HealthCare LLC.

----------

Lotrimin Ultra ®

Antifungal

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

Questions?

866-360-3226

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 30g Tube Carton

LOTRIMIN ULTRA®

butenafine hydrochloride cream 1%
ANTIFUNGAL

NET WT 30g (1.1 OZ)

PRINCIPAL DISPLAY PANEL - 30g Tube Carton
LOTRIMIN ULTRA  ANTIFUNGAL
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7154
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)  
DIETHANOLAMINE (UNII: AZE05TDV2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETETH-23 (UNII: 495CTZ441V)  
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7154-11 in 1 CARTON02/22/200209/01/2017
112 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11523-7154-21 in 1 CARTON02/22/200209/01/2017
224 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11523-7154-31 in 1 CARTON02/22/200209/01/2017
330 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:11523-7154-41 in 1 CARTON02/01/200209/01/2017
415 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130709/23/1993
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 2/2017
Document Id: 47e50ab6-5028-0fe0-e054-00144ff8d46c
Set id: 0eadac26-4619-4227-9dda-28e739d77a87
Version: 3
Effective Time: 20170206
 
Bayer HealthCare LLC.