MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]

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MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]
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NDC 63736-018-03
Set ID 153d0891-1770-4825-aa03-1bd6c504812a
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals
Generic Name
Product Class Azole Antifungal
Product Number
Application Number NDA020670
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  • 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

    PRINCIPAL DISPLAY PANEL - Kit Carton

    3 DAY TREATMENT • CREAM

    MONISTAT® 3
    Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
    (Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
    VAGINAL ANTIFUNGAL

    CLINICALLY PROVEN
    MULTI-SYMPTOM RELIEF

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

    COMBINATION PACK

    Net Wt. 0.18 oz. (5g) each applicator • 0.32 oz. (9g) tube

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    MONISTAT 3 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-018
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-018-031 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
    NDANDA02067012/10/2009
    Part 2 of 2
    MICONAZOLE NITRATE 
    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)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    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
    NDANDA02067012/10/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067012/10/2009
    Labeler - Insight Pharmaceuticals (176792315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jubilant246762764MANUFACTURE(63736-018)
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