NAIL MD (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]

NAIL MD (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]
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NDC 55992-711-01
Set ID bf425745-09db-4290-9329-b1760051c93e
Category HUMAN OTC DRUG LABEL
Packager OMG Medical Group, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

  • INACTIVE INGREDIENT

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

  • ACTIVE INGREDIENT

    miconazole nitrate 2% USP

  • PURPOSE

    Topical antifungal

  • 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)

  • 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

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    keep this and all medications out of the reach of children

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NAIL MD 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55992-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE200 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BIOTIN (UNII: 6SO6U10H04)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55992-711-01200 mg in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/14/2013
    Labeler - OMG Medical Group, LLC (038837214)
    Establishment
    NameAddressID/FEIBusiness Operations
    OMG Medical Group, LLC038837214repack(55992-711)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(55992-711)

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