Label: ANTI-FUNGAL BUTTERY BALM LADY BITS- miconazole nitrate 2% ointment

  • NDC Code(s): 72839-133-01
  • Packager: Derma Care Research Labs, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 6, 2019

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  • ACTIVE INGREDIENT

    Miconazole Nitrate 2%

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  • PURPOSE

    Antifungal

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  • DOSAGE & ADMINISTRATION

    Cures most tinea cruris "jock itch" and tinea corporis "ring worm". Soothes itching, burning, cracking.

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  • WARNINGS

    For external use only.

    Avoid contact with eyes. Do not use on children under 2 years of age unless directed by a doctor.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • INDICATIONS & USAGE

    Clean the affected area thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

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  • INACTIVE INGREDIENT

    aloe barbadensis leaf extract, althaea officinalis root extract, beeswax, butyrospermum park ii (shea) butter, calendula officinalis flower extract, cocos nucifera (coconut) oil, cucumis melo (melon) fruit extract, dipteryx odorata seed extract, glycerin, hydrogenated vegetable oil, olea europaea (olive) fruit oil, pimpinella anisum (anise) fruit extract, ricinus communis (castor) seed oil, theobroma cacao (cocoa) extract, triethyl citrate, vanilla planifolia fruit extract, water

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  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL BUTTERY BALM  LADY BITS
    miconazole nitrate 2% ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-133
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCOA (UNII: D9108TZ9KG)  
    VANILLA (UNII: Q74T35078H)  
    WATER (UNII: 059QF0KO0R)  
    MELON (UNII: 5CIT1X6U5V)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CORN OIL (UNII: 8470G57WFM)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ANISE (UNII: 21C2F5E8RE)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72839-133-01 25 g in 1 JAR; Type 0: Not a Combination Product 05/03/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 05/03/2019
    Labeler - Derma Care Research Labs, LLC (116817470)
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