Label: KERASAL ATHLETES FOOT POWDER- tolnaftate spray

  • 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

    (To Deliver) Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis)
    • Helps prevent most athlete's foot with daily use
    • For effective relief of itching, cracking, burning, scaling and discomfort
  • Warnings

    For external use only

    Extremely Flammabledo not use while smoking or near heat or flame.

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

    When using this productavoid contact with the eyes

    • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
    • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

    Stop use and ask 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
    • Shake can well and spray 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

    alcohol, aloe vera leaf, alpha-tocopherol acetate, butylated hydroxytoluene, ceramide NG, dimethicone, eucalyptus oil, isobutane, isododecane, methylal, peppermint oil, tapioca starch, tea tree oil

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 56 g Can Label

    Tolnaftate Antifungal
    Kerasal ®

    NEW

    For Athlete's Foot

    Invisible Powder Spray

    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 2.0 oz (56 g)

    PRINCIPAL DISPLAY PANEL - 56 g Can Label
  • INGREDIENTS AND APPEARANCE
    KERASAL ATHLETES FOOT POWDER 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-110
    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
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-110-0157 g in 1 CAN; Type 0: Not a Combination Product02/28/2022
    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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