FORTINIA OF (CLOTRIMAZOLE 1%) SOLUTION [THE PODIATREE COMPANY]

FORTINIA OF (CLOTRIMAZOLE 1%) SOLUTION [THE PODIATREE COMPANY]
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NDC 54633-017-01
Set ID 60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f
Category HUMAN OTC DRUG LABEL
Packager The Podiatree Company
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

  • Flammable

    Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat.

  • 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

    Ethyl Alcohol (79%), Propylene Glycol

  • Questions or Suggestions?

    1.855.763.8733 or visit us at www.thepodiatreecompany.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FORTINIA OF 
    clotrimazole 1% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-017
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-017-0129.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/05/2017
    Labeler - The Podiatree Company (078656000)

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