Label: FUNGUS MASTER ANTIFUNGAL TREATMENT- miconazole nitrate lotion

  • NDC Code(s): 72654-001-01, 72654-001-02
  • Packager: Ebanel Laboratories, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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

  • DRUG FACTS

  • Active Ingredient

    Miconazole Nitrate 2%

    Purpose

    Antifungal

  • Uses

    • Proven clinically effective in the treatment of most athlete’s foot(Tinea Pedis), jock itch(Tinea Cruris) and ringworm(Tinea Corporis).
    • For effective relief of itching, scaling, cracking, burning, redness, Soreness, irritation, discomfort, itchy, scaly skin between the toes, and chafing associated with jock itch.
  • Warnings

    • Do not use on children under 2 years of age.
    • For external use only.
    • Avoid contact with the eyes.
    • If irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Wash 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 persists longer, consult a doctor. This product is not effective on the scalp or nails. Store at 15-30°C (59-86°F)

  • Other Information

    Functional ingredients used in this formula have been shown to improve the appearance of thickened, discolored, and unhealthylooking feet caused by dermatophytic fungi. Urea has been shown to thin, soften, and act as penetrating agent on skin. Undecylenic acid is effective as an emulsifier, cleanser, and preservative.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cinnamomum Zeylanicum Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Cymbopogon Flexuosus Oil, Dimethyl Isosorbide, Dodecane, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Lavandula Angustifolia (Lavender) Flower Oil, Leptospermum Scoparium Branch/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Oreganum Vulgare Leaf Oil, Panthenol, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, PEG-8 Dilaurate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phospholipids, Polysorbate 20, Polysorbate 60, PPG-26-Buteth-26, Punica Granatum Seed Extract, Retinyl Palmitate, Salicylic Acid, Santalum Spicatum Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Bicarbonate,Tocopheryl Acetate,Undecylenic Acid, Inact ive Ingredients Urea, Water

  • Package Labeling:

    123

  • INGREDIENTS AND APPEARANCE
    FUNGUS MASTER ANTIFUNGAL TREATMENT 
    miconazole nitrate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72654-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    DODECANE (UNII: 11A386X1QH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-8 DILAURATE (UNII: FC11NGP7E6)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    POMEGRANATE SEED (UNII: 7294Z34NS7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72654-001-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/01/2019
    2NDC:72654-001-0259 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/01/2019
    Labeler - Ebanel Laboratories, Inc (079352161)