MICONOLE (MICONAZOLE NITRATE) CREAM [OPTION LABS]

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MICONOLE (MICONAZOLE NITRATE) CREAM [OPTION LABS]
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NDC 43645-112-45
Set ID 52057f7d-377e-4dd9-809e-fcdb8c214998
Category HUMAN OTC DRUG LABEL
Packager Option Labs
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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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