Label: MEDLINE- miconazol nitrate ointment

  • NDC Code(s): 53329-172-10
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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

  • Active ingredient

    Miconazole nitrate 2.0% w/w

  • Purpose

    Antifungal

  • Uses

    • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), 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 a doctor
    • on scalm or nails

    When using this product

    • avoid contact with 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 of ointment 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
  • Other information

    • protect from freezing
    • avoid excessive heat
  • Inactive ingredient

    7-dehydrocholesterol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea (olive) fruit oil, petrolatum, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in the USA of domestic and imported materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC092625

    V2 RH22PUA

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    miconazol nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CLOVE (UNII: K48IKT5321)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CORN OIL (UNII: 8470G57WFM)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-172-1071 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2024
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)