Label: MICONAZOLE NITRATE cream

  • 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 15, 2023

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

  • Drug Facts

  • Active ingredient

    Miconazole Nitrate USP 2%

  • Purpose

    Antifungal

  • Uses

    • 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 and discomfort that can accompany these conditions.
  • Warnings

    For external use only
    Do not use on children less than 2 years of age unless directed by a doctor
    When using this product avoid contact with eyes
    Stop use and ask a doctor if • irritation occurs • condition persist • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • clean 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
    • not effective on the scalp or nails
  • Inactive ingredients

    Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

  • Other information

    • Do not use if seal is damaged or is not visible. • To open, unscrew cap, pull tab to remove foil seal • store at room temperature not exceeding 30​°​C (86​°​F). Do not freeze. • see carton or tube crimp for lot number and expiration date

  • Questions or comments?

    1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

  • SPL UNCLASSIFIED SECTION

    CURES MOST ATHLETE'S FOOT

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

    Compared to the active ingredient in Micatin

    Distributed by.

    ARU PHARMA INC.
    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Micnzle1

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-924
    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)  
    CETETH-20 (UNII: I835H2IHHX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70403-924-301 in 1 CARTON01/01/201803/31/2025
    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 finalpart333C01/01/201803/31/2025
    Labeler - Aru Pharma Inc. (079736192)