Label: MICONAZOLE NITRATE- miconazole nitrate cream

  • NDC Code(s): 0713-0252-37
  • Packager: Cosette Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 19, 2019

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

  • ACTIVE INGREDIENT

    Miconazole nitrate 2% (100 mg in each applicator)
    Miconazole nitrate 2% (as external cream)

  • PURPOSE

    Vaginal antifungal

  • USES

    • treats repeat vaginal yeast infections
    • relieves external itching and irritation due to a repeat vaginal yeast infection

  • 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 medication warfarin, because bleeding or bruising may occur.

    When using this product
    • do not use tampons, douches, spermicides, or other vaginal products
    • do not have vaginal intercourse
    • condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

    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.

  • DOSAGE & ADMINISTRATION

    • before using this product read the enclosed consumer information leaflet for complete instructions
    • adults and children 12 years of age and over:
             • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
             • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated  
                 skin outside the vagina. Use daily for up to 7 days as needed
    • children under 12 years of age: ask a doctor

  • OTHER INFORMATION

    • do not use if seal over tube opening has been punctured or cannot be seen
    • store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.

  • INACTIVE INGREDIENT

    benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

  • QUESTIONS

    1-800-922-1038

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    Miconazole Nitrate Vaginal Cream 2%
    Vaginal Antifungal
    7 Day Vaginal Cream
    Relieves external vulvar itching and irritation associated with a yeast infection
    CURES MOST VAGINAL YEAST INFECTIONS
    NET WT 1.59 OZ (45g)

    Unit Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE  
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0252
    Route of AdministrationVAGINAL
    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)  
    PEG-5 OLEATE (UNII: 0240V77G50)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0713-0252-3745 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/22/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07436602/22/1996
    Labeler - Cosette Pharmaceuticals, Inc. (116918230)
    Registrant - Cosette Pharmaceuticals, Inc. (116918230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals, Inc.116918230analysis(0713-0252) , manufacture(0713-0252) , label(0713-0252) , pack(0713-0252)