Label: CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM- clotrimazole 1% antifungal cream cream

  • NDC Code(s): 73715-004-01
  • Packager: Mohnark Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 23, 2024

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Clotrimazole 1%

  • PURPOSE

    Antifungal

    cures most athlete's foot, jock itch and ringworm

    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

    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)

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE AND ASK DOCTOR IF

    irritation occurs
    there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

  • DIRECTIONS

    • wash affected area and dry thoroughly
    • apply 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 the 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
  • OTHER INFORMATION

    • To open: unscrew cap, remove liner seal and replace cap
    • Store at USP controlled room temperature 20-25°C (68-77°F)
    • see carton or tube crimp for lot number and expiration date
  • INACTIVE INGREDIENTS

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • DOSAGE AND ADMINISTRATION

    10 milligrams/gram per application

  • INDICATIONS AND USAGE

    Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
    Children under 2 years of age: consult a doctor

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • PRINCIPAL DISPLAY PANEL

    Clotrimazole 1% Carton

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 1% TOPICAL ANTIFUNGAL CREAM 
    clotrimazole 1% antifungal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 1 g  in 100 g
    WATER (UNII: 059QF0KO0R) 69.5 g  in 100 g
    POLYSORBATE 60 (UNII: CAL22UVI4M) 1.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73715-004-0128 g in 1 TUBE; Type 0: Not a Combination Product12/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/21/2020
    Labeler - Mohnark Pharmaceuticals Inc. (117013830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mohnark Pharmaceuticals Inc.117013830manufacture(73715-004)