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 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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 or sealed vaginal insert blister 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

PRINCIPAL DISPLAY PANEL

Kit Carton

MONISTAT®
Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL | COMBINATION PACK

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: 63736-013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-013-30	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	06/29/2001

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; Type 0: Not a Combination Product

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; Type 0: Not a Combination Product

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 LLC (055665422)