Label: CLOTRIMAZOLE- family wellness clotrimazole cream

  • NDC Code(s): 69396-038-05
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 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. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

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

  • Warnings

    Do not use on children under 2 years of age except under the advice of a doctor.

    ● For external use only

    ● 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 within 2 weeks (for jock itch).
  • If Pregnant or breastfeeding

    If Pregnant or breastfeeding, ask a health professional before use.

  • 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

    Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

  • Other Information

    • store at controlled room temperature 20°-25°C (68°- 77°F)
    • Close cap tightly after use.
  • Questions or Comments?

    Call 1-888-296-9067 Mon-Fri 9AM - 5PM

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

    500 Volvo Parkway, Chesapeake, VA. 23320

    NOT SATISFIED?

    Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

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

  • Packaging

    family wellness clotrimazole 05oz

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    family wellness clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-038
    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
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-23 (UNII: N72LMW566G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-038-051 in 1 BOX08/30/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/30/2019
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)