Label: CLOTRIMAZOLE cream

  • NDC Code(s): 69396-087-01, 69396-087-55
  • Packager: TRIFECTA PHARMACEUTICALS USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 28, 2024

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

  • Active ingredient

    Clotrimazole USP 1% w/w

  • Purpose

    Antifungal Cream

  • 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 Center right away.

  • Uses

    Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

  • Warnings

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

    ● For external use only

    ● Avoid contact with eyes.

  • Stop Use and ask a Doctor

    Irritation occurs

    There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 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 (morning and night), or as directed by a doctor.

    ● 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, consult a doctor.

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

  • Inactive Ingredients

    Cetamacragol 1000, Cetostearyl alcohol, mineral oil, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum.

  • Other Information

    • store at controlled room temperature 15°-30°C (59°- 86°F)
    • Close cap tightly after use.
  • Questions?

    Adverse drug event call 1-888-296-9067

    Dist. By Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL 33301, USA

    Made in India

    www.trifecta-pharma.com

    Globe Clotrimazole Anti-Fungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin AF.

  • Packaging

    clotrimazole-1oz-22-CDR

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-087
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    CETETH-20 (UNII: I835H2IHHX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-087-011 in 1 BOX06/04/2022
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-087-555 in 1 BOX04/08/2022
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/08/2022
    Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)