MICONAZOLE 7- miconazole nitrate cream 
Cardinal Health (Leader) 70000

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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 (1-800-222-1222) 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: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • do not use if foil seal on tube opening is broken or missing
  • do not purchase if carton is open
  • store at room temperature 20°-25°C (68-77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

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

Question?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

COMPARE TO MONISTAT® 7 VAGINAL CREAM active ingredient*

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 and Irritation

7 DAY VAGINAL CREAM (1 TUBE)

WITH 1 REUSABLE APPLICATOR

NET WT OZ (g)

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label

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

LEADER Vaginal Antifungal

MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0009
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0009-11 in 1 CARTON07/01/2019
145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416407/01/2019
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 3/2023
 
Cardinal Health (Leader) 70000