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Monistat 3 Combination Pack 3 Ovule Inserts

Dosage form: kit
Ingredients: Miconazole Nitrate 200mg; Miconazole Nitrate 20mg in 1g
Labeler: Insight Pharmaceuticals
NDC Code: 63736-019

MONISTAT® 3 Day Combination Pack (3 Day Ovule Insert plus External Cream)

Drug Facts

Active ingredientPurpose
Miconazole nitrate (200 mg in each vaginal insert)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 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 disease (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 after 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 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 (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 or embossed design is not visible

  • do not purchase if carton is open
  • store at 20° - 25°C (68° to 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


Distributed by: McNEIL-PPC, Inc., Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Carton

3 DAY TREATMENT • OVULE® INSERTS

MONISTAT® 3
Miconzole Nitrate Vaginal Inserts (200mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

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

COMBINATION PACK

Net Wt. 3 OVULE® Inserts • 0.32oz (9g) tube

MONISTAT 3 COMBINATION PACK  3 OVULE INSERTS
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-019
Packaging
#Item CodePackage Description
1NDC:63736-019-031 KIT in 1 PACKAGE, COMBINATION
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 AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin 
Glycerin 
Titanium Dioxide 
Packaging
#Item CodePackage Description
13 SUPPOSITORY in 1 KIT
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 AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Cetyl Alcohol 
Isopropyl Myristate 
Polysorbate 60 
Potassium Hydroxide 
Propylene Glycol 
Water 
Stearyl Alcohol 
Packaging
#Item CodePackage Description
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/FEIOperations
Jubilant246762764MANUFACTURE

Revised: 06/2012
 
Insight Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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