Label: NAIL MD- miconazole nitrate cream

  • NDC Code(s): 55992-711-01
  • Packager: OMG Medical Group, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/13

If you are a consumer or patient please visit this version.

  • WARNINGS

    do not use on children under two years of age except under the advce and supervision of a doctor

    stop use and ask a doctor if irritation occurs, if condition worsesn, or there is not improvement within four weeks

    for external use only

    avoid contact with eyes, scalp, vagina, penis, scrotum and anus

    do not ingest

    do not use on open wounds

    in case of accidental ingestion, contact a physician, emergency medical

    do not use if you are known to be sensitive to any of the ingredients in this product

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  • INACTIVE INGREDIENT

    aqua (deionized water), biotin, dimethyl sulfone (msm), ethyoxydiglycol, ethylhexylglycerin, hydrolyzed keratin proteins, hydroxyethylcellulose, phenoxyethanol, polysorbate 20, sd alcohol 40B

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  • ACTIVE INGREDIENT

    miconazole nitrate 2% USP

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  • PURPOSE

    Topical antifungal

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  • uses

    antifungal drying agent

    is indicated for candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes

    as well as somegram postivie bacteria

    lessens the signs of nail dystophy (nail damage caused by trauma or diseas such as fungal infection)

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  • directions

    shake well before using

    clean and dry affected areas

    apply twice per day or as recommended by your doctor

    with the brush applicator a thin layer of the product making sure to coat both the nail and cuticle completely

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  • other information

    store at controlled room temperature 15-30 degrees celsius (59-86 degrees farenhight)

    protect from heat

    keep from freezing, if freezing occurs, thaw out at room temperature and shake well to mix contents back to a solution

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  • KEEP OUT OF REACH OF CHILDREN

    keep this and all medications out of the reach of children

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  • INGREDIENTS AND APPEARANCE
    NAIL MD 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55992-711
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 200 mg  in 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    BIOTIN  
    WATER  
    DIMETHYL SULFONE  
    BIS-ETHOXYDIGLYCOL SUCCINATE  
    ETHYLHEXYLGLYCERIN  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
    PHENOXYETHANOL  
    POLYSORBATE 20  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55992-711-01 200 mg in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 02/14/2013
    Labeler - OMG Medical Group, LLC (038837214)
    Establishment
    Name Address ID/FEI Business Operations
    OMG Medical Group, LLC 038837214 repack(55992-711)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source 969241041 manufacture(55992-711)
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