Label: MICONOLE- miconazole nitrate cream

  • 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 August 15, 2013

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  • Drug Facts

    Miconazole Nitrate 2%

    Aloe Vera Polysaccharide 1%

  • Purpose

    Antifungal

    Other ingredients:

    Allantoin, Cetyl Alcohol, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Stearic Acid, Fragrance

  • Uses

    for the treatment of

    • athletes foot (tinea pedis)
    • jock itch (tinea cruris)
    • ringworm (tinea corporis)
    • superficial skin infections caused by yeast (candida albicans)
  • Warnings

    for external use only

    • do not use on children under 2 years of age unless directed by a doctor
    • avoid contact with eyes
    • If irritation occurs or if there is no improvement within 2 weeks, discontinue use and see a doctor

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash 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 ringworm use daily for 4 weeks, if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails.
  • Other Information

    Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).  See USP Controlled Room Temperature.

  • Comments

    You may report side effects to FDA at 1-800-FDA-1088

  • PRINCIPAL DISPLAY PANEL

    Miconole Label

    NDC 43645-112-45

    Manufactured for:

    Option Labs.

    801 Noble St., 8th Floor Commerce Tower

    Anniston, AL 36201

    Miconole

    (miconazole nitrate 2%) Cream

    with Aloe Vera (proprietary patented

    polysaccharides from heart of aloe)

    Net Wt. 1.5 oz.

    Rev. 02/13

  • INGREDIENTS AND APPEARANCE
    MICONOLE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43645-112
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43645-112-451 in 1 CARTON
    142.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/15/2013
    Labeler - Option Labs (078380329)
    Registrant - Option Labs (078380329)
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