FORTINIA (CLOTRIMAZOLE) CREAM [THE PODIATREE COMPANY]

  • Home
  • FORTINIA (CLOTRIMAZOLE) CREAM [THE PODIATREE COMPANY]

FORTINIA (CLOTRIMAZOLE) CREAM [THE PODIATREE COMPANY]
PDF | XML
NDC 54633-314-80
Set ID 60ba6f8a-8617-d4f6-e053-2991aa0a4a71
Category HUMAN OTC DRUG LABEL
Packager The Podiatree Company
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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 affected area and dry thoroughly
    • apply a thin layer to the affected area twice daily (morning and night)
    • 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 socks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks
    • if condition persists longer, consult your doctor
    • this product is not effective on the scalp or nails
  • Other information

    Store at controlled room temperature

  • Questions or Suggestions?

    1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

    completely satisfied, please contact us directly for a full refund.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FORTINIA 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL L-ARGININE (UNII: W6957UBY9Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-314-8080 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/02/2015
    Labeler - The Podiatree Company (078656000)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Contract Packaging048602791manufacture(54633-314)
View All Sections

Related Drugs

Search DailyMed Drugs