BUTENAFINE HYDROCHLORIDE JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WAL-MART STORES INC]

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  • BUTENAFINE HYDROCHLORIDE JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WAL-MART STORES INC]

BUTENAFINE HYDROCHLORIDE JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WAL-MART STORES INC]
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NDC 49035-178-08
Set ID be9a411c-55d7-4db5-a420-30013efbbc24
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
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 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?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    NDC 49035-178-08

    equate™

    Compare to Lotrimin Ultra® Jock Itch Active Ingredient*

    CONTAINS THE DRUG:
    BUTENAFINE HYDROCHLORIDE

    Butenafine Hydrochloride Cream 1%
    Antifungal

    Clinically Proven To Cure Most Jock Itch

    • Prescription Strength
    • Relieves Itching, Burning and Chafing

    NET WT
    0.42 OZ (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BUTENAFINE HYDROCHLORIDE   JOCK ITCH
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-178
    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:49035-178-081 in 1 CARTON12/14/2018
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20518111/16/2017
    Labeler - Wal-Mart Stores Inc (051957769)
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