Your browser does not support JavaScript! 7 DAY VAGINAL (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH]
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RxNorm Names

7 DAY VAGINAL (miconazole nitrate) cream
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

Label
7 DAY VAGINAL  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-590
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Butylated Hydroxyanisole 
Mineral Oil 
Peg-5 Oleate 
Pegoxol 7 Stearate 
Water 
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
 
Cardinal Health

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