Miconazole Nitrate Vaginal Cream, USP

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-935-2362

Websitewww.qualitychoice.comwww.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections
  
• relieves external itching and irritation due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday–Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in MONISTAT® 7 Vaginal Cream

Miconazole 7

Miconazole Nitrate Vaginal Cream USP, 2%

Vaginal Antifungal

(Miconazole Nitrate 100 mg per applicator)

Cures Most Vaginal Yeast Infections and Relieves

Associated External Itching and Irritation

OZ NET WT (g) Tube  Vaginal Cream with Reusable Applicator

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

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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• Miconazole 7
• Miconazole Nitrate
• MICONAZOLE
• BENZOIC ACID
• BUTYLATED HYDROXYANISOLE
• MINERAL OIL
• APRICOT KERNEL OIL PEG-6 ESTERS
• PEGOXOL 7 STEARATE
• WATER

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