Monistat 1 Combination Pack

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

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 NDC Product Code (Source) 30014-012

Packaging # NDC Package Description Multilevel Packaging 1 30014-012-30 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 1200 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 1 SUPPOSITORY In 1 POUCH None

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

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 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: 04/2010McNeil, PPC, Inc.

More Monistat 1 Combination Pack resources

• Monistat 1 Combination Pack Use in Pregnancy & Breastfeeding
• Monistat 1 Combination Pack Drug Interactions
• Monistat 1 Combination Pack Support Group
• 8 Reviews for Monistat Combination Pack - Add your own review/rating

Compare Monistat 1 Combination Pack with other medications

• Cutaneous Candidiasis
• Oral Thrush
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Vaginal Yeast Infection