Label: TERBINAFINE HYDROCHLORIDE cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 8, 2024

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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 eyes
    • for vaginal yeast infections

    When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor iftoo 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 over:
      • 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
  • 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 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    Athlete's Foot Cream

    TERBINAFINE HYDROCHLORIDE CREAM 1% / ANTIFUNGAL

    NET WT 1 OZ (30 g)

    cream-01

  • INGREDIENTS AND APPEARANCE
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4502
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4502-021 in 1 CARTON10/25/2023
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751110/25/2023
    Labeler - WALGREEN COMPANY (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(0363-4502)
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