Label: CAREALL MICONAZOLE NITRATE- miconazole nitrate cream

  • NDC Code(s): 51824-078-01
  • Packager: New World Imports, Inc
  • 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 December 1, 2020

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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.
    • Fore effective relief of itching, scaling, burning and discomfort that can accompany these conditions.
  • 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
    • condition persists
    • there is no improvement of athlete's foot or ringworm within 4 weeks and jock itch within 2 weeks
  • Directions

    • clean the 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
    • not effective on the scalp or nails
  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    miconazole 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 NITRATE2 g  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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    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 finalpart333C12/01/2020
    Labeler - New World Imports, Inc (075372276)