Label: LOTRIMIN ULTRA ATHLETES FOOT- butenafine hydrochloride cream

  • NDC Code(s): 11523-4338-1, 11523-4338-2, 11523-4338-4
  • Packager: Bayer Healthcare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 14, 2023

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  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    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 AF 4338

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN ULTRA  ATHLETES FOOT
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4338
    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:11523-4338-11 in 1 CARTON02/22/2002
    112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11523-4338-21 in 1 CARTON02/22/2002
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11523-4338-41 in 1 CARTON02/22/2002
    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)
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