Label: ATHLETES FOOT- terbinafine hydrochloride cream

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

Drug Label Information

Updated April 26, 2024

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

View All Sections
  • 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 productdo 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
      • 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 footwear 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 weekor as directed by a doctor.
        • on the bottom or sides of the foot:apply twice a day (morning and night) for 2 weeksor as directed by a doctor.
      • for jock itch and ringworm:apply once a day (morning ornight) for 1 weekor as directed by a doctor.
      • wash hands after each use
    • children under 12 years: ask a doctor
    		Figure
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
    • store at controlled room temperature 20° to 25°C (68° to 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?

    Call 1-800-910-6874

  • SPL UNCLASSIFIED SECTION

    Dist. by Target Corp.
    Mpls., MN 55403

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    up & up

    full prescription strength
    athlete's foot cream
    terbinafine hydrochloride 1% – antifungal

    helps cure most athlete's foot, jock itch and ringworm
    helps relieve itching, burning, cracking and scaling

    NET WT 1 OZ (30 g)

    terbinafine-02

  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE1 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:11673-080-021 in 1 CARTON03/25/2015
    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 - Target Corporation (006961700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(11673-080)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!