MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]

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MICONAZOLE (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-291-01
Set ID 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Drug Facts

  • Active ingredient

    Miconazole nitrate, USP 2%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
    • for effective relief of itching, scaling, cracking, 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

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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
    • if condition lasts longer, contact a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • do not use if foil seal on tube opening is broken or missing
    • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
    • store at room temperature 15-30°C (59-86°F)
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO THE ACTIVE INGREDIENT IN MICARIN® ANTIFUNGAL CREAM*

    Antifungal Cream

    Miconazole nitrate cream, USP 2%

    Cures Most

    Athlete's Foot,

    Jock Itch & Ringworm.

    Soothes Itching, Scaling, Cracking, and Burning

    *This product is not manufactured or distributed by WellSpring Pharmaceutical Corporation, distributor of Micatin® Antifungal Cream.

    Distributed By: Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

  • Package label

    Miconazole Nitrate, USP 2%

    PREMIER VALUE Antifungal Cream

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-291
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-291-011 in 1 CARTON05/15/2009
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C05/15/2009
    Labeler - Chain Drug Consortium, LLC (101668460)
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