Label: JOCK ITCH- butenafine hydrochloride cream

  • NDC Code(s): 51672-2101-1, 51672-2101-2, 51672-2101-8, 51672-2101-9
  • Packager: Taro Pharmaceuticals U.S.A., inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 20, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Butenafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch
    • 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 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
      • 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), propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Clinically Proven to Cure Most Jock Itch

    Butenafine
    Hydrochloride Cream 1%

    Antifungal
    NET WT 15 g (0.53 oz)

    Principal Display Panel - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    JOCK ITCH 
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2101
    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)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl stearate SE (UNII: FCZ5MH785I)  
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2101-81 in 1 CARTON11/17/2017
    112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2101-11 in 1 CARTON11/17/2017
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51672-2101-91 in 1 CARTON11/17/2017
    324 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51672-2101-21 in 1 CARTON11/17/2017
    430 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20518111/17/2017
    Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2101)
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