LOTRIMIN ULTRA ANTIFUNGAL- butenafine hydrochloride cream 
Bayer HealthCare LLC.

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Lotrimin Ultra ®

Antifungal

Drug Facts

Active ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
  • cures most jock itch and ringworm
  • relieves itching, burning, cracking, and scaling which accompany these conditions

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:
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
    • for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor

Other information

  • do not use if seal on tube is broken or not visible
  • store between 20° to 25°C (68° to 77°F)

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
NDANDA02130709/23/199309/01/2017
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 5/2024
 
Bayer HealthCare LLC.