Label: MICONAZOLE NITRATE cream

  • NDC Code(s): 51672-2001-1, 51672-2001-2
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • 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 January 30, 2020

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  • SPL UNCLASSIFIED SECTION

    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, 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 persists
    • 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. 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
  • Other information

    • To open: unscrew cap, use pointed end on cap to puncture seal
    • store at 20° - 25°C (68° - 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals
    U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Cures Most Athlete's Foot

    Antifungal Cream

    Miconazole Nitrate
    Cream USP, 2%
    Antifungal Cream

    NET WT 1/2 oz (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2001
    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
    apricot kernel oil (UNII: 54JB35T06A)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    glycol stearate (UNII: 0324G66D0E)  
    mineral oil (UNII: T5L8T28FGP)  
    polyethylene glycol 300 (UNII: 5655G9Y8AQ)  
    water (UNII: 059QF0KO0R)  
    PEG-6 stearate (UNII: 8LQC57C6B0)  
    PEG-32 stearate (UNII: 33GX5WQC0M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2001-11 in 1 CARTON10/01/1991
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2001-21 in 1 CARTON10/01/1991
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C10/01/1991
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2001)
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