Label: SILKA GEL- terbinafine hydrochloride gel

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

Drug Label Information

Updated January 26, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athletes foot (tinea pedis)
    • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, burning, cracking and scaling which accompany this condition
  • 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 product do not get into 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 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 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 bottom or sides of feet: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
      • for jock itch and ringworm: apply twice a day (morning and night) for 1 week or as directed by a doctor.
      • wash hands after each use
    • children under 12 years: ask a doctor
  • Other information

    • do not use if seal on tube is broken or is 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 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    PCGI Wholesale Chula Vista, CA, 91911

  • PRINCIPAL DISPLAY PANEL - 30g Tube Carton

    Silka Gel

  • INGREDIENTS AND APPEARANCE
    SILKA  GEL
    terbinafine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51769-121
    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:51769-121-3030 g in 1 TUBE; Type 0: Not a Combination Product01/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751101/18/2021
    Labeler - All Natural Dynamics (962732892)
    Registrant - All Natural Dynamics (962732892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gelpharma S.A. de C.V.812773665manufacture(51769-121)