Label: FORTICEPT ANTIFUNGAL FOOT CREAM- clotrimazole cream

  • 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 April 12, 2020

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Active Ingredient/Purpose

    Clotrimazole - 1% (Antifungal)

  • Uses

    • Cures most athlete's foot, jock itch and ringworm
    • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
    • Helps keep feet dry and free of fungal infection

    For the treatment of fungal infections caused by: Athlete's foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis)

  • WARNINGS:

    For external use only!

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

  • ASK DOCTOR

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

  • WHEN USING

    When using this product avoid contact with eyes.

  • DIRECTIONS:

    Adults and children 2 years of age and older:
    • wash affected area and dry thoroughly
    • apply a thin layer over affected area once or twice daily
    • 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

  • Inactive Ingredients:

    ALUMINUM STARCH OCTENYLSUCCINATE, CETEARETH-20, CETOSTEARYL ALCOHOL, DIPROPYLENE GLYCOL, ETHYLHEXYLGLYCERIN, GLYCERYL MONOSTEARATE, HYPROMELLOSE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, TEA TREE OIL, PEPPERMINT OIL, PHENOXYETHANOL, POLIHEXANIDE, WATER

  • Other Information:

    • To open: unscrew cap and remove the seal.
    • Store between 68° - 77°F (20° - 25°C)

  • For Questions:

    Please call: +1 212 709-8133
    Lidan, Inc.
    30 Wall Street, 8th Floor
    New York, NY 10005
    www.forticept.com

  • PRINCIPAL DISPLAY PANEL

    Forticept Antifungal Foot Cream Tube Label

  • INGREDIENTS AND APPEARANCE
    FORTICEPT ANTIFUNGAL FOOT CREAM 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72127-0801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72127-0801-00.114 kg in 1 TUBE; Type 0: Not a Combination Product04/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/12/2020
    Labeler - Lidan, Inc. (014456716)
    Registrant - Lidan, Inc. (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(72127-0801) , relabel(72127-0801) , pack(72127-0801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmex Group, LLC.365309015manufacture(72127-0801) , relabel(72127-0801) , repack(72127-0801) , pack(72127-0801)