Label: MICONAZOLE NITRATE cream

  • NDC Code(s): 61269-735-14, 61269-735-42, 61269-735-56
  • Packager: H2-Pharma, LLC
  • 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 June 23, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate USP, 2%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
    • for effective relief of itching, scaling, cracking, burning, and discomfort
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a 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) or within 2 weeks (for jock itch)

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

  • 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 the 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 lasts longer, contact a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • do not use if foil seal on tube opening is broken or missing
    • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
    • store at room temperature 15°-30°C (59°-86°F)
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Miconazole Nitrate Cream USP, 2%
    Antifungal Cream

    NDC 61269-735-56
    *Compare to the active ingredient in
    Micatin® Antifungal Cream

    Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven

    Net wt. 1 oz (28 g)

    H2 pharma

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-735
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61269-735-141 in 1 CARTON06/29/2021
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:61269-735-561 in 1 CARTON06/29/2021
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:61269-735-421 in 1 CARTON06/29/2021
    342.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/29/2021
    Labeler - H2-Pharma, LLC (028473634)