Label: FORTICEPT ANTIFUNGAL COOLING- clotrimazole liquid

  • Category: HUMAN OTC DRUG LABEL

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 4, 2016

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  • Active Ingredient/Purpose

    Clotrimazole USP 1%........................Antifungal

    Uses

    • cures most athlete’s foot infections (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) 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 direceted by a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

    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
    • Spray a thin layer over 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 the toes, wear well-fitting, ventilated shoes and change socks at least once daily
    • For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if condition persists longer, ask a doctor. This product is not effective on the scalp or nails
  • SPL UNCLASSIFIED SECTION

    Other Information  store between 20° - 25°C (68° - 77°F)

  • Inactive ingredients:

    Aquaxyl, Dicaprylyl Carbonate, Dimethicone, Eucalyptus Oil, Glycerin, Lavender Oil, Montanov L, Oat Milk, Polyhexanide, Sepimax Zen, Simulgel INS100, Sodium Phytate, Sunflower Oil, Tea Tree Oil, Water

  • 60g

    60g

  • 120g

    120g

  • INGREDIENTS AND APPEARANCE
    FORTICEPT ANTIFUNGAL COOLING 
    clotrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R) 858.5 g  in 1000 g
    glycerin (UNII: PDC6A3C0OX) 20 g  in 1000 g
    dimethicone (UNII: 92RU3N3Y1O) 20 g  in 1000 g
    oat (UNII: Z6J799EAJK) 15 g  in 1000 g
    C14-22 Alcohols (UNII: B1K89384RJ) 15 g  in 1000 g
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 10 g  in 1000 g
    sunflower oil (UNII: 3W1JG795YI) 10 g  in 1000 g
    polydextrose (UNII: VH2XOU12IE) 10 g  in 1000 g
    polihexanide hydrochloride (UNII: 4XI6112496) 10 g  in 1000 g
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.s at 1%) (UNII: 86FQE96TZ4) 3.4 g  in 1000 g
    isohexadecane (UNII: 918X1OUF1E) 3.3 g  in 1000 g
    polysorbate 60 (UNII: CAL22UVI4M) 3.3 g  in 1000 g
    lavender oil (UNII: ZBP1YXW0H8) 3 g  in 1000 g
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 3 g  in 1000 g
    PHYTATE SODIUM (UNII: 88496G1ERL) 2 g  in 1000 g
    eucalyptus oil (UNII: 2R04ONI662) 2 g  in 1000 g
    Tea Tree oil (UNII: VIF565UC2G) 1.5 g  in 1000 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0502-060 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2016
    2NDC:52261-0502-1120 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/04/2016
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0502) , label(52261-0502) , pack(52261-0502)
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