Label: MICONAZOLE 3- miconazole nitrate cream

  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2014

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


    Drug Facts

  • Active ingredient (in each applicator)

    Miconazole Nitrate USP 4% (200 mg in each applicator)

  • Purpose

    Vaginal antifungal

  • Use

    • treats vaginal yeast infections
  • Warnings

    For vaginal use only

    Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

    Ask a doctor before use if you have

    • vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition.
    • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

    Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

    When using this product

    • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching or irritation may occur
    • if you do not get complete relief ask a doctor before using another product.

    Stop use and ask a doctor if

    • symptoms do not get better in 3 days
    • symptoms last more than 7 days
    • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • before using this product read the consumer information leaflet for complete directions and information
    • adults and children 12 years of age and over:
      • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.
      • Throw applicator away after use.
    • children under 12 years of age: ask a doctor
  • Other information

    • store at 20°-25°C (68°-77°F)
    • do not purchase if carton is open
    • see end flaps of carton and end of tube for lot number and expiration date
    • the tube opening should be sealed. If seal has been broken, do not use product.
  • Inactive ingredients

    cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

  • Questions?

    Call 1-866-923-4914


    Manufactured for Shopko
    By Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1

  • PRINCIPAL DISPLAY PANEL - 25 g Tube Carton


    Miconazole 3
    Miconazole Nitrate Vaginal Cream USP (4%)
    Vaginal Antifungal
    (Miconazole Nitrate 200 mg Per Applicator)

    3 Day Treatment

    Consumer Information
    Leaflet Enclosed

    NDC 37012-070-09

    *Compare to the active
    ingredient in Monistat® 3*

    One 0.9 oz (25 g) Tube of 3 Day Vaginal Cream with 3 Disposable Applicators

    PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-070
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    cetyl alcohol (UNII: 936JST6JCN)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-070-091 in 1 CARTON
    125 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(37012-070)