Label: EQUATE ATHLETES FOOT- terbinafine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Terbinafine Hydrochloride 1%

    Close
  • Purpose

    Antifungal

    Close
  • 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
    Close
  • 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.

    Close
  • 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 2 weeks on the bottom or sides of the foot
    Figure Figure
    Close
  • Other information

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

    benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

    Close
  • Questions?

    Call toll free: 1-888-287-1915

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716.

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    EQUATE   ATHLETES FOOT
    terbinafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-080
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Terbinafine Hydrochloride (Terbinafine) Terbinafine 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    cetyl alcohol  
    cetyl palmitate  
    isopropyl myristate  
    polysorbate 60  
    water  
    sodium hydroxide  
    sorbitan monostearate  
    stearyl alcohol  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-080-03 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077511 07/02/2007
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Taro Pharmaceticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49035-080)
    Close