Label: KERASAL ATHLETES FOOT POWDER- tolnaftate spray

  • 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 May 25, 2022

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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 Flammable do not use while smoking or near heat or flame.

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

    When using this product avoid 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 FINALpart333C02/28/2022
    Labeler - Advantice Health, LLC (192527062)
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