Label: DERMASANA- miconazole nitrate and triclosan cream 

  • NDC Code(s): 55992-023-01
  • 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 03/13

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

  • Warnings

    do not used on children under two years of age except under the advice and supervision of a doctor

    stop use and ask a doctor if irritation occurs, if conditions worsens, 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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  • active ingredient

    miconazole nitrate 2% USP

    triclosan 0.3% USP

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  • purpose

    topical antifungal

    topical antibacterial

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications our of the reach of children

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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 to the affected areas

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  • uses

    antifungal drying agent

    antibacterial drying agent

    is indicated in the treatment of most fungi

    athlete's foot (tinea pedis)

    ringworm (tinea corporis)

    jock itch (tinea cruris)

    candida albicans

    trichophyton rubrum

    malassezia furfur

    trichophyton mentagrophytes

    epidemophyton floccsum

    is indicated for the treatment of most bacteria

    gram positive bacteria (such as staphyloocccous aureus)

    is indicated for certain methicillin resistant saphylococcus aureus (MRSA) isolates

    is indicated for most coagulase-negative staphylococci

    beta hemolytic streptococci

    corynebacterium species

    clostridium species

    anaerobic gram-negative bacilli (such as bacteriodes fragilis)

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  • other information

    store at controlled room temperature 15-30 degrees celcius (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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  • INACTIVE INGREDIENT

    acetic acid, aqua (deionized water), benzyl alcohol, c13-14 isoparaffin, ethylhexylglycerin, laureth 7, parfum, phenoxyethanol, polyacrylamide, polysorbate 20, sd-alcohol 40B

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  • INGREDIENTS AND APPEARANCE
    DERMASANA 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55992-023
    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
    TRICLOSAN (TRICLOSAN) TRICLOSAN 30 mg  in 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACETIC ACID  
    WATER  
    BENZYL ALCOHOL  
    C13-14 ISOPARAFFIN  
    ETHYLHEXYLGLYCERIN  
    LAURETH-7  
    PHENOXYETHANOL  
    POLYACRYLAMIDE (10000 MW)  
    POLYSORBATE 20  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55992-023-01 200 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(55992-023)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source 969241041 manufacture(55992-023)
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