ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]

  • Home
  • ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]

ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]
PDF | XML
NDC 36800-049-01
Set ID 3e976ed8-2af8-4d1e-bda6-e2f672c7ec03
Category HUMAN OTC DRUG LABEL
Packager TOPCO ASSOCIATES LLC
Generic Name
Product Class Benzylamine Antifungal
Product Number
Application Number ANDA205181
View All Sections
  • 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.
    • cures most jock itch and ringworm
    • relieves itching, burning, cracking, and scaling which accompany these conditions
  • 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
      • 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
  • 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?

    Call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    TopCare®
    health™

    PRESCRIPTION STRENGTH

    Athlete's Foot Cream Ultra

    BUTENAFINE HYDROCHLORIDE CREAM 1% • ANTIFUNGAL

    NET WT 0.42 OZ (12 g)

    OUR PHARMACISTS
    • RECOMMEND •

    Principal Display Panel - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    butenafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-049
    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:36800-049-011 in 1 CARTON12/12/2017
    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 - TOPCO ASSOCIATES LLC (006935977)
View All Sections

Related Drugs

Search DailyMed Drugs