ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]

ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]
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NDC 69842-986-02, 69842-986-03, 69842-986-08
Set ID 5ef3c059-fc25-42da-89c7-b5dab9991795
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class Benzylamine Antifungal
Product Number
Application Number ANDA205181
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Butenafine hydrochloride 1%

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  • Purpose

    Antifungal

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  • 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
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  • 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.

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  • 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.
        Apply between and around the toes

        Figure

        1 week twice a day or 4 weeks once a day
      • 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
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  • Other information

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

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

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  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    CVSHealth

    Butenafine Hydrochloride
    Cream 1%

    Antifungal Cream
    Prescription Strength

    NET WT 1 OZ (30 g)
    Package Contains One Tube

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    butenafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-986
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Butenafine Hydrochloride (UNII: R8XA2029ZI) (Butenafine - UNII:91Y494NL0X) Butenafine Hydrochloride 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-986-08 1 in 1 CARTON 11/17/2017
    1 12 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:69842-986-02 1 in 1 CARTON 11/17/2017
    2 30 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:69842-986-03 1 in 1 CARTON 11/21/2019
    3 30 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA205181 11/17/2017
    Labeler - CVS Pharmacy (062312574)
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