Label: CAREALL CLOTRIMAZOLE- clotrimazole cream

  • NDC Code(s): 51824-063-01
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Keep out of Reach of Children

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    • Cures most athlete's foot, jock itch and ringworm.
    • Relieves itching, burning, cracking, scaling, and discomfort.
  • 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 doctor if

    • irritation occurs
    • there is no improvement in 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) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • for atlete'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
  • Inactive Ingredients

    Ceteareth 20, Cetostearyl Alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Water, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    AFCL1 Carton

  • INGREDIENTS AND APPEARANCE
    CAREALL CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    clotrimazole (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) clotrimazole10 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-063-0128 g in 1 TUBE; Type 0: Not a Combination Product03/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/21/2016
    Labeler - New World Imports, Inc (075372276)
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