7 DAY VAGINAL- miconazole nitrate cream

7 DAY VAGINAL by

Drug Labeling and Warnings

7 DAY VAGINAL by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, G & W Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

Purpose

Vaginal antifungal

Uses

• treats repeat vaginal yeast infections

• relieves external itching and irritation due to a repeat 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 medication warfarin, because bleeding or bruising may occur.

When using this product

• do not use tampons, douches, spermicides, or other vaginal products

• do not have vaginal intercourse

• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

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 instructions

• adults and children 12 years of age and over:

  • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
  • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as needed

• children under 12 years of age: ask a doctor

Other information

• do not use if seal over tube opening has been punctured or cannot be seen

• store at room temperature 15°-30°C (59-86°F). Avoid heat over 30°C or 86°F.

Inactive ingredients

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions?

1-800-200-6313

PRINCIPAL DISPLAY PANEL

NDC: 37205-590-29

LEADER®

7 DAY VAGINAL CREAM
Miconazole NitrateVAGINAL CREAM 2% VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections.
Relieves external vulvar itching and irritation associated with a yeast infection

Compare to Monistat® 7 active ingredient*

NET WT 1.59 OZ (45 g)

SATISFACTION GUARANTEED

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OH 43017
CIN 1362490

www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

*This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT® 7. MONISTAT® 7 is a registered trademark of Johnson & Johnson.

10-25237LR2

INGREDIENTS AND APPEARANCE

7 DAY VAGINAL  
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-590
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)
Butylated Hydroxyanisole (UNII: REK4960K2U)
Mineral Oil (UNII: T5L8T28FGP)
Peg-5 Oleate (UNII: 0240V77G50)
Pegoxol 7 Stearate (UNII: 3EW5AXE5X5)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-590-29	45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/16/2009

Labeler - Cardinal Health (097537435)

Registrant - G & W Laboratories, Inc. (001271188)

Establishment
Name	Address	ID/FEI	Business Operations
G & W Laboratories, Inc.		001271188	MANUFACTURE(37205-590)