Label: MONISTAT 3 COMBINATION PACK- miconazole nitrate kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 2, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
    (2%)
    Vaginal Antifungal

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Miconazole nitrate (200 mg in each suppository)Vaginal antifungal
    Miconazole nitrate 2% (external cream)Vaginal antifungal
  • Uses

    • treats vaginal yeast infections
    • relieves external itching and irritation due to a 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 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 enclosed consumer information leaflet for complete directions and information
    • adults and children 12 years of age and over:
    • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
    • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
    • children under 12 years of age: ask a doctor
  • Other information

    • do not use if printed suppository blister is torn, open or incompletely sealed

    • do not use if seal over tube opening has been punctured or embossed design embossed design is not visible

    • do not purchase if carton is open
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    suppository: hydrogenated vegetable oil base

    external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

  • QUESTIONS

    Questions? If you have any questions or comments, please call 1-877-666-4782
    Visit our website @ www.monistat.com

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    3 DAY TREATMENT • SOFT INSERTS

    MONISTAT® 3
    Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)
    (Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)
    VAGINAL ANTIFUNGAL

    CURES MOST VAGINAL YEAST INFECTIONS
    and relieves associated external itching and irritation

    CLINICALLY PROVEN
    MULTI-SYMPTOM RELIEF

    COMBINATION PACK

    Net Wt. 3 Suppositories • 0.32 oz. (9g) tube

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MONISTAT 3 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-016
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-016-031 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 3 
    Part 21 TUBE 9 g
    Part 1 of 2
    MONISTAT 3 
    miconazole nitrate suppository
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/16/1996
    Part 2 of 2
    MONISTAT 3 
    miconazole nitrate cream
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate10 mg  in 0.5 g
    Inactive Ingredients
    Ingredient NameStrength
    benzoic acid (UNII: 8SKN0B0MIM)  
    cetyl alcohol (UNII: 936JST6JCN)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    19 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/16/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/16/1996
    Labeler - Insight Pharmaceuticals (176792315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jubilant246762764MANUFACTURE(63736-016)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!