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Monistat 1 Combination Pack

Pronunciation

Generic Name: miconazole nitrate
Dosage Form: vaginal insert, external cream

Monistat 1 Day Night

Drug Facts

Active ingredients Purpose
Miconazole nitrate 1200 mg (in 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

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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 the applicator, place the vaginal insert into the vagina. 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 pouch is 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°-77°F)
  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

Inactive ingredients

  • vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum
  • 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 - Kit Carton

NDC-30014-012-30

MONISTAT® 1
COMBINATION PACK

Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)

CLINICALLY PROVEN
ORTHO
STAYS IN PLACE

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

1 OVULE® Insert with Applicator
Plus External Cream

ORTHO

Net Wt 1 OVULE® Insert
+ 0.32 oz (9g) Tube

Monistat 1 Combination Pack 
miconazole nitrate kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30014-012
Packaging
# Item Code Package Description
1 NDC:30014-012-30 1 KIT (KIT) in 1 PACKAGE, COMBINATION
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 POUCH
Part 2 1 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
     
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (Miconazole) Miconazole Nitrate 1200 mg
Packaging
# Item Code Package Description
1 1 SUPPOSITORY (SUPPOSITORY) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021308 04/15/2010
Part 2 of 2
MICONASOLE NITRATE 
miconazole nitrate cream
Product Information
     
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g
Packaging
# Item Code Package Description
1 9 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021308 04/15/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021308 04/15/2010
Labeler - McNeil, PPC, Inc. (801375143)
Revised: 04/2010
 
McNeil, PPC, Inc.



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