LOTRIMIN ULTRA RINGWORM- butenafine hydrochloride cream 
Bayer Healthcare LLC.

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Lotrimin Ultra

Ringworm

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

adults and children 12 years and older:

children under 12 years: ask a doctor

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?

Questions? 1-866-360-3266 or visit us a www.lotrimin.com

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PDP

LOTRIMIN ULTRA  RINGWORM
butenafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0158
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
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
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0158-21 in 1 CARTON07/31/2024
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130701/02/2024
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 7/2024
Document Id: 1c4562a1-1423-c0e6-e063-6294a90ad643
Set id: 1b438ca7-fd5f-62cb-e063-6294a90ab3a6
Version: 2
Effective Time: 20240702
 
Bayer Healthcare LLC.