MONISTAT 1 COMBINATION PACK- miconazole nitrate kit

Monistat 1 Combination Pack by

Drug Labeling and Warnings

Monistat 1 Combination Pack by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals, Jubilant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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 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 pouch is torn, open or incompletely sealed
• do not use if seal over tube opening has been punctured
• 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?

call toll-free 877-666-4782

SPL UNCLASSIFIED SECTION

Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053

PRINCIPAL DISPLAY PANEL - Kit Carton

1 DAY TREATMENT OVULE® INSERT

MONISTAT® 1
Miconazole Nitrate Vaginal Insert (1200mg) 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

# 1 DOCTOR
RECOMMENDED BRAND†

Net Wt. 1 OVULE® Insert 0.32oz (9g) tube

INGREDIENTS AND APPEARANCE

MONISTAT 1 COMBINATION PACK 
miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-014-03	1 in 1 PACKAGE, COMBINATION

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	1200 mg

Inactive Ingredients
Ingredient Name	Strength
Gelatin (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
Mineral Oil (UNII: T5L8T28FGP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021308	06/29/2001

Part 2 of 2

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
Cetyl Alcohol (UNII: 936JST6JCN)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Polysorbate 60 (UNII: CAL22UVI4M)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021308	06/29/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021308	06/29/2001

Labeler - Insight Pharmaceuticals (176792315)

Establishment
Name	Address	ID/FEI	Business Operations
Jubilant		246762764	MANUFACTURE(63736-014)