Label: CLOTRIMAZOLE 1%- 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 January 11, 2023

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

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control right away.

  • Uses

    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 except under the advice and supervision of 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 ringwork) or 2 weeks (for jock itch).
  • Directions

    • Wash the affected area and dry thoroughly.

    ● Apply a thin layer of this product over affected area twice daily.

    ● 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 shoes and 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 conditions persists longer, ask a doctor.

    ● This product is not effective on the scalp or nails.

  • Inactive Ingredients

    Alcohol, Butylated Hydroxytoluene, Dimethyl Sulfoxide, Ethylparaben, Glycerol, Polyoxyethylene lauryl ether, Light Mineral Oil, Petrolatum, Cetostearyl Alcohol, purified Water, mono and di-glycerides, edetate disodium

  • Other Information

    • store at room temperature 20°-25°C (68°- 77°F)
  • Questions or Comments?

    DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www. meijer.com

    Made in China

    This product is not manufactured or distributed by Bayer Healthcare LLC., owner of the registered trademark Lotrimin®.

  • If Pregnant or Breast-Feeding

    Ask a Health Professional before use.

  • Keep out of reach of Children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Packaging

    CDER-Meifer Clotrimazole cream

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 1% 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0014
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-23 (UNII: N72LMW566G)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0014-11 in 1 BOX04/20/2021
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/20/2021
    Labeler - Meijer (006959555)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)