Label: EQUATE ATHLETES FOOT- terbinafine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 8, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis)
    • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
    • 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 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
      • To open: unscrew cap, pull tab to remove foil seal and screw cap back onto the tube
      • wash the affected skin with soap and water and dry completely before applying
      • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
      • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
    • wash hands after each use
    • children under 12 years: ask a doctor

    1 week between the toes

    Figure

    2 weeks on the bottom or sides of the foot

    Figure

  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    Benzyl Alcohol, Cetyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Purified Water, Sodium Hydroxide, Sorbitan Monostearate, Stearyl Alcohol.

  • Questions?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 49035-080-03

    equate™

    Compare to
    Lamisil AT®
    Active
    Ingredient*

    Athlete's
    Foot

    Terbinafine
    Hydrochloride 1%
    Antifungal Cream

    Cures Most
    Athlete's Foot

    • Relieves Itching & Burning
    • Full Prescription Strength

    NET WT 1 OZ (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE   ATHLETES FOOT
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetyl palmitate (UNII: 5ZA2S6B08X)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-080-031 in 1 CARTON07/02/2007
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751107/02/2007
    Labeler - Wal-Mart Stores Inc (051957769)