Label: FORTINIA- clotrimazole 1% solution

  • 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 December 20, 2017

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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 finalpart333C10/01/2014
    Labeler - The Podiatree Company (078656000)
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