Label: CAREALL MICONAZOLE NITRATE- miconazole nitrate cream

  • NDC Code(s): 51824-078-01
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • Active Ingredient

    Miconazole Nitrate 2%

  • 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 right away (1-800-222-1222).

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
    • For effective relief of itching, scaling, burning 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 avoide contact with eyes

    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 of the 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 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 condition persists longer, consult a doctor
    • not effective on the scalp or nails
  • Inactive Ingredients

    Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    AFMC1 Carton Label

  • INGREDIENTS AND APPEARANCE
    CAREALL MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-078-0128 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/01/2020
    Labeler - New World Imports, Inc (075372276)
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