Label: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS- miconazole nitrate kit

  • NDC Code(s): 63736-019-03
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 15, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Miconazole nitrate (200 mg in each vaginal insert)

    Miconazole nitrate 2% (external cream)

  • Purpose

    Vaginal antifungal

    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 applicator away 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 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?

    If you have any questions or comments, please call 1-877-666-4782 

  • PRINCIPAL DISPLAY PANEL

    MONISTAT® 3 COMBINATION PACK

    Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%)

    VAGINAL ANTIFUNGAL

    3 OVULE® Inserts with 3 Applicators (Net Wt. 3 OVULE® Inserts)

    plus External Cream for Itch Relief (0.32 oz (9 g) Tube

    PRINCIPAL DISPLAY PANEL
MONISTAT® 3 COMBINATION PACK
Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 
VAGINAL ANTIFUNGAL

3 OVULE® Inserts with 3 Applicators (Net Wt. 3 OVULE® Inserts) 
plus External Cream for Itch Relief (0.32 oz (9 g) Tube

  • INGREDIENTS AND APPEARANCE
    MONISTAT 3 COMBINATION PACK  3 OVULE INSERTS
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-019
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-019-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/16/1996
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 KIT
    Part 21 TUBE 9 g
    Part 1 of 2
    MICONAZOLE NITRATE 
    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
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 in 1 KIT; Type 1: Convenience Kit of Co-Package
    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 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)  
    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 - Insight Pharmaceuticals LLC (055665422)