Label: MICONAZOLE 3- miconazole nitrate kit

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 6, 2017

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  • SPL UNCLASSIFIED SECTION

  • Active ingredients

    Miconazole nitrate (200 mg in each vaginal insert)

  • Purpose

    Vaginal antifungal

  • Active ingredients

    Miconazole nitrate 2% (external cream)

  • Purpose

    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:

    •vaginal insert: with a disposable applicator place the insert into the vagina at bedtime. 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 (vulva). 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 sealed pouches containing vaginal inserts are torn, open, or incompletely sealed

    •do not use if seal over tube opening has been punctured

    •do not purchase if carton is open

    •store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

  • Questions? call toll-free 1-855-590-5695

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients of Monistat® 3
    3-Day Treatment; 3-Step System
    Yeast Infection Relief
    Miconazole 3
    MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)
    MICONAZOLE NITRATE CREAM (2%)
    Vaginal Antifungal
    Combination Pack

    • Cures most vaginal yeast infections
    • Relieves associated external itching & irritation

    3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
    NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

    PRINCIPAL DISPLAY PANEL
Compare to the active ingredients of Monistat® 3
3-Day Treatment; 3-Step System
Yeast Infection Relief 
Miconazole 3
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES (200 mg)
MICONAZOLE NITRATE CREAM (2%)
Vaginal Antifungal
Combination Pack
•	Cures most vaginal yeast infections
•	Relieves associated external itching & irritation
3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9g) TUBE

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 3 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-950
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-950-011 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package04/16/1996
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 APPLICATOR
    Part 21 TUBE 9 g
    Part 1 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate insert
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CORN OIL (UNII: 8470G57WFM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/16/1996
    Part 2 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 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; Type 0: Not a Combination Product
    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 - CVS Pharmacy (062312574)
    Registrant - Insight Pharmaceuticals (078774214)