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7 DAY VAGINAL

Dosage form: cream
Ingredients: Miconazole Nitrate 2g in 100g
Labeler: Cardinal Health
NDC code: 37205-590

Medically reviewed by Drugs.com. Last updated on Jan 2, 2024.

DRUG FACTS

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

7 DAY VAGINAL  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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/FEIOperations
G & W Laboratories, Inc.001271188MANUFACTURE(37205-590)

 
Cardinal Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.