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Monistat 3 Combination Pack 3 Ovule Inserts

Medically reviewed on June 1, 2018

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

 
Insight Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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