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
  • 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 December 28, 2020

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

  • 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 finalpart333C12/21/2020
    Labeler - Mohnark Pharmaceuticals Inc. (117013830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mohnark Pharmaceuticals Inc.117013830manufacture(73715-004)