Label: LOTRIMIN ULTRA- butenafine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 22, 2021

If you are a consumer or patient please visit this version.

  • 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.
    • relieves itching, burning, cracking, and scaling which accompany this condition
  • 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

    When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if too much irritation occurs or irritation gets worse

  • KEEP OUT OF REACH OF CHILDREN

    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:
      • wash the affected skin with soap and water and dry completely before applying
      • to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream.
      • 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.
      • wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
      • wash hands after each use
    • children under 12 years: ask a doctor
  • Other information

    • 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

  • Questions?

    1-866-360-3266 or visit us at www.lotrimin.com

  • PRINCIPAL DISPLAY PANEL

    ​LOTRIMIN ULTRA ®

    BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL

    NET WT 20g (0.70 OZ)

    Lotrimin Ultra

  • INGREDIENTS AND APPEARANCE
    LOTRIMIN ULTRA 
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0082
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETETH-23 (UNII: 495CTZ441V)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0082-11 in 1 CARTON12/20/2021
    120 g in 1 TUBE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02130712/20/2021
    Labeler - Bayer Healthcare LLC. (112117283)