Label: FORTINIA- clotrimazole 1% solution

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

Drug Label Information

Updated January 8, 2026

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete’s foot infections and ringworm infections
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

  • 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 eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor or pharmacist if

    • irritation occurs
    • there is no improvement within 4 weeks

  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

  • Directions

    • wash affected area and dry thoroughly
    • apply one drop to the affected area twice daily (morning and night) or as directed by your doctor
    • using a disposable cotton swab, spread a thin layer over the affected area
    • discard cotton swab
    • supervise children in the use of this product
    • for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • for athlete’s foot and ringworm infections, use daily for 4 weeks
    • this product is not effective on scalp or nails

  • Other Information

    Store at controlled room temperature.

  • Inactive Ingredients

    Aloe barbadensis leaf extract, lavandula augustifolia (lavender) oil, olea europaea (olive) leaf extract, PEG 400, polysorbate 80, SD alcohol (9.75%), tocopheryl acetate (Vitamin E), tritium vulgare (wheat) germ oil

  • Questions or Suggestions?

    1.855.763.8733 or visit us at www.thepodiatreecompany.com

  • PRINCIPAL DISPLAY PANEL

    label

    Label

  • INGREDIENTS AND APPEARANCE
    FORTINIA 
    clotrimazole 1% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-214-0129.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/01/2014
    Labeler - The Podiatree Company (078656000)
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