Miconazole Nitrate Vaginal Cream, USP

Drug Facts

Active ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

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:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
- use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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

to open tube use cap to puncture seal
do not use if seal over tube opening has been punctured or is not visible
do not purchase if carton is open
store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal display panel

fred’s Pharmacy
NDC 55315-730-63
7 DAY VAGINAL CREAM
1 TUBE WITH 1 REUSABLE APPLICATOR

Miconazole 7
MICONAZOLE NITRATE VAGINAL CREAM, USP 2%
(MICONAZOLE NITRATE 100 MG PER APPLICATOR)
VAGINAL ANTIFUNGAL

• Cures Most Vaginal Yeast Infections
• Relieves Associated External Itching & Irritation

NET WT 1.59 OZ (45g) TUBE

Compare To Active Ingredient in *Monistat® 7 Vaginal Cream

MICONAZOLE 7
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-730
Route of Administration	VAGINAL

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

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55315-730-63	1 in 1 CARTON	06/09/2009	12/31/2017
1		45 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074164	06/09/2009	12/31/2017

Labeler - Fred's Inc. (005866116)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 4/2019

Document Id: fb17a51b-b197-4f56-9b5b-d2239dcc6212

Set id: d9e3f2e7-2848-4d95-b2ae-7f863e7b1a07

Version: 9

Effective Time: 20190418

Fred's Inc.