Label: MICONAZOLE NITRATE CREAM 2%- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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

  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

  • Warnings

    For external use only

    Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash

    When using this product • avoid contact with the eyes

    Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm

    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 cream 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

    • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date

  • Inactive Ingredients

    Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum

  • Questions or comments?

    718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

  • SPL UNCLASSIFIED SECTION

    Cures Most Athlete's Foot

    Compared to the active ingredient in Micatin®*

    Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

    *This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin®

    Distributed by:

    EzriCare, LLC

    Lakewood, NJ

    www.EzriCare.com

    Made in India

  • Packaging

    Ezricare-106

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE CREAM 2% 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79503-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79503-106-301 in 1 CARTON08/19/202107/01/2025
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/19/202107/01/2025
    Labeler - Ezricare Llc (117573818)