OTC Medication Information: Miconazole 7

MICONAZOLE 7- miconazole nitrate cream
QUALITY CHOICE (Chain Drug Marketing Association)

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

F o r vaginal use only

Do not use

i f 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

Questions?

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

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

Miconazole nitrate USP, 2% (100 mg in each applicator)
(click image for full-size original)

QUALITY CHOICE Vaginal Antifungal Cream

MICONAZOLE 7 miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-198
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
MINERAL OIL
APRICOT KERNEL OIL PEG-6 ESTERS
PEGOXOL 7 STEARATE
WATER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-198-45 1 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
1 45 g in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (63868-198-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074164 07/01/2010
Labeler — QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 09/2022 QUALITY CHOICE (Chain Drug Marketing Association)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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