Label: MEDLINE- miconazole nitrate cream

  • NDC Code(s): 53329-147-44
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient

    Miconazole nitrate 2.0% w/v

  • Purpose

    Antifungal

  • Uses

    • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) or ringworm (tinea corporis)
    • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
  • Warnings

    For external use only

    Do not use

    • on children under 2 years of age unless directed by doctor

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor

    • if irritation occurs
    • there is no improvement within 4 weeks for athlete’s foot and ringworm
    • there is no improvement within 2 weeks for jock itch

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily or as directed by a physician
    • supervise use by children
    • 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 four weeks; for jock itch, use daily for two weeks
    • if condition persists longer, consult a doctor
    • this product is not effective on scalp or nails
  • Other information

    • protect from freezing
    • avoid excessive heat
  • Inactive ingredients

    acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil PEG-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCL, retinyl palmitate, silica, tocopherol, triethanolamine, vanillin, water, zea mays oil

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and foreign materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC092604

    V1 RL22WAS

  • Package Label

    Label V1 RL22WAS

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-147
    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
    GLYCINE (UNII: TE7660XO1C)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    WATER (UNII: 059QF0KO0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TAURINE (UNII: 1EQV5MLY3D)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    MANDARIN OIL (UNII: NJO720F72R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYDROXYTYROSOL (UNII: QEU0NE4O90)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-147-44118 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/01/2023
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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