Label: KERASAL FOR ATHLETES FOOT SILKY CLEAR- tolnaftate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis)
    • clinically proven to prevent most Athlete's Foot with daily use
    • for effective relief of itching, cracking, burning, scaling and discomfort
  • Warnings

    For external use only

    Do not useon children under 2 years of age unless directed by a doctor.

    When using this productavoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks.

    Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • wash the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
    • this product is not effective on the scalp or nails
  • Other information

    Store between 20-25°C (68-77°F)

  • Inactive ingredients

    aloe vera leaf, alpha tocopheryl acetate, ceramide NG, dimethicone, dimethicone crosspolymer, eucalyptus oil, isododecane, peppermint oil, tea tree oil

  • Questions?

    1-877-674-3475
    www.Kerasal.com

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    NEW

    Tolnaftate Antifungal
    Kerasal ®

    For Athlete's Foot

    Silky Clear Gel

    5 IN 1™

    CURES
    Most Athlete s Foot

    PREVENTS
    Recurrence

    RELIEVES
    Itching, Burning And Scaling

    NOURISHES
    Improves Skin Appearance

    DEODORIZES
    With Essential Oils

    Enriched with Natural Tea Tree Oil,
    Aloe, Ceramides & Vitamin E

    NET WT 0.42 oz (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KERASAL FOR ATHLETES FOOT SILKY CLEAR 
    tolnaftate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-100-011 in 1 CARTON02/28/2022
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/28/2022
    Labeler - Advantice Health, LLC (192527062)
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