7 DAY VAGINAL - miconazole nitrate cream 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredient

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

Purpose

Vaginal antifungal

Uses

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

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

Stop use and ask a doctor if

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

Other information

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

Label
7 DAY VAGINAL  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-590
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-590-2945 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/16/2009
Labeler - Cardinal Health (097537435)
Registrant - G & W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIBusiness Operations
G & W Laboratories, Inc.001271188MANUFACTURE(37205-590)

Revised: 1/2011
Document Id: 90f4c811-0f40-659f-f9f5-5c57a4ff74c2
Set id: 1b95ccd9-ce8d-50cb-2db1-05ad9924811a
Version: 1
Effective Time: 20110112
 
Cardinal Health