Monistat 3 Combination Pack Triple Action

Dosage Form: cream
Monistat 3 Triple Action System

Drug Facts

Active ingredients	Purpose
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 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 at bedtime for 3 nights in a row. 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 or embossed design

  
  


• 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 - kit carton

NDC-30014-002-03

MONISTAT®3

COMBINATION PACK

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

ORTHO

CLINICALLY PROVEN

Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND

RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

3 OVULE® Inserts With 3 Applicators

PLUS External Cream

Net Wt 3 OVULE® Inserts

+ 0.32 oz (9g) Tube

MONISTAT 3 COMBINATION PACK  TRIPLE ACTION miconazole nitrate  kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-002

Packaging # NDC Package Description Multilevel Packaging 1 30014-002-03 1 KIT In 1 PACKAGE, COMBINATION None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 POUCH   1  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 40 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 3 POUCH In 1 KIT contains a POUCH 1 1 SUPPOSITORY In 1 POUCH This package is contained within the KIT

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 9 g In 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 04/15/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020670	04/15/2010

Labeler - McNeil, PPC, Inc. (801375143)

Revised: 04/2010McNeil, PPC, Inc.

More Monistat 3 Combination Pack Triple Action resources

• Monistat 3 Combination Pack Triple Action Use in Pregnancy & Breastfeeding
• Monistat 3 Combination Pack Triple Action Drug Interactions
• Monistat 3 Combination Pack Triple Action Support Group
• 8 Reviews for Monistat 3 Combination Pack Triple Action - Add your own review/rating

Compare Monistat 3 Combination Pack Triple Action with other medications

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