Label: SILKA ANTIFUNGAL- terbinafine hydrochloride cream

  • NDC Code(s): 50066-080-02, 50066-080-03, 50066-080-05
  • Packager: Genomma Lab USA, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 10, 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?

    1 877 994 3666Monday to Friday, 8 am to 6 pm Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc., Houston, TX, 77027

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    Terbinafine Hydrochloride Cream 1% - Antifungal

    SILKA ®

    ANTIFUNGAL CREAM FOR ATHLETE'S FOOT

    Full prescription strength

    NET WT.
    1 oz (30 g)

    IMAGE-01

  • INGREDIENTS AND APPEARANCE
    SILKA   ANTIFUNGAL
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-080
    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:50066-080-021 in 1 CARTON07/02/2007
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50066-080-031 in 1 CARTON05/21/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50066-080-051 in 1 CARTON12/20/2018
    315 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 - Genomma Lab USA, Inc. (832323534)
    Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(50066-080)