JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WALGREEN COMPANY]

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JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WALGREEN COMPANY]
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NDC 0363-2101-08
Set ID 6b13e8ad-b7dd-49e7-9469-3cac077c763e
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Benzylamine Antifungal
Product Number
Application Number ANDA205181
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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 20º to 25º C (68º to 77º 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?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    Walgreens

    Butenafine
    Hydrochloride Cream 1%

    ANTIFUNGAL

    NET WT 0.42 OZ (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    JOCK ITCH 
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2101
    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:0363-2101-081 in 1 CARTON11/17/2017
    112 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 - Walgreen Company (008965063)
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