Label: SILKA ANTIFUNGAL- tolnaftate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • For effective treatment of most athlete's foot and ringworm
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.
  • Warnings

    For external use only

    • Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm).

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly
    • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • Supervise children in the use of this product
    • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • To prevent athlete's foot, apply once or twice daily (morning and/or night)
    • Apply to skin around the nail and cuticle.
  • Other information

    • Store at room temperature 15° – 30°C (59° -86°F)
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

  • Questions or comments?

    Call toll free 1-877-994-3666

    Monday to Friday, 8 am to 6 pm Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab., Houston, TX 77027

  • PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton

    SILKA®

    MAX STRENGTH

    ANTIFUNGAL
    LIQUID

    »
    KILLS
    FUNGUS
    »
    STOPS ITCHING
    AND BURNING
    »
    HELPS RESTORE
    SKIN HEALTH

    BEFORE
    AFTER
    DRAMATIZATION

    WITH BRUSH
    APPLICATOR

    CLINICALLY PROVEN
    AGAINST ATHLETE'S
    FOOT FUNGUS

    0.45 FL OZ / 13 ML

    PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SILKA ANTIFUNGAL 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-083-011 in 1 CARTON03/22/2022
    113 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/22/2022
    Labeler - Genomma Lab USA (832323534)
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