MICONAZOLE 3- miconazole nitrate kit

Miconazole 3 by

Drug Labeling and Warnings

Miconazole 3 by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Purpose

Vaginal antifungal

Active ingredients

Miconazole nitrate 2% (external cream)

Purpose

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 a disposable applicator place the insert into the vagina at bedtime. 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

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? call toll-free 1-855-590-5695

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Monistat® 3
3-Day Treatment; 3-Step System
Yeast Infection Relief
Miconazole 3
MICONAZOLE NITRATE VAGINAL INSERTS (200 mg)
MICONAZOLE NITRATE CREAM (2%)
Vaginal Antifungal
Combination Pack

• Cures most vaginal yeast infections
  
• Relieves associated external itching & irritation

3 VAGINAL SOFTGEL INSERTS, 3 APPLICATORS, 1 EXTERNAL CREAM, 4 FEMININE WIPES
NET WT 3 VAGINAL SOFTGEL INSERTS + 0.32 OZ (9 g) TUBE

INGREDIENTS AND APPEARANCE

MICONAZOLE 3 
miconazole nitrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-950

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-950-01	1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package	04/16/1996

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 APPLICATOR	3
Part 2	1 TUBE	9 g

Part 1 of 2

MICONAZOLE NITRATE 
miconazole nitrate insert

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	200 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
CORN OIL (UNII: 8470G57WFM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020670	04/16/1996

Part 2 of 2

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 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	NDA020670	04/16/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020670	04/16/1996

Labeler - CVS Pharmacy (062312574)

Registrant - Insight Pharmaceuticals (078774214)