MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS- miconazole nitrate kit

Monistat 7 Combination Pack by

Drug Labeling and Warnings

Monistat 7 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

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate  
Insight Pharmaceuticals

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MONISTAT® 7 Combination Pack

Drug Facts

Active ingredient

Miconazole nitrate (100 mg in each applicator)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

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 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 disease (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 after 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:
  ▪ applicators: insert 1 applicatorful into the vagina at bedtime for 7 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 not use if seal over tube opening has been punctured
  
• do not purchase if carton is open
  
• store at 20° - 25°C (68° to 77°F)

Inactive ingredients

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

MONISTAT® 7 

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (2%) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

VAGINAL CREAM

with 7 Disposable Applicators                    Net Wt. 1.59 oz. (45g)

plus External Cream for Itch Relief                 + 0.32 oz. (9g) tube

INGREDIENTS AND APPEARANCE

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS
miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-023

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-023-15	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	04/26/1993

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	7 TUBE, WITH APPLICATOR	35 g
Part 2	1 TUBE	9 g

Part 1 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		5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017450	04/26/1993

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	NDA017450	04/26/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017450	04/26/1993

Labeler - Insight Pharmaceuticals LLC (055665422)