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Miconazole Nitrate by Preferred Pharmaceuticals Inc.

Medically reviewed on December 14, 2017

Dosage form: cream
Ingredients: Miconazole Nitrate 20mg in 1g
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-8985

Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole Nitrate USP 2% (100 mg per 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 after 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 directions and information
adults and children 12 years of age and over:
applicator: insert one 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: ask a doctor

Other information
do not purchase if carton is opened
do not use if seal over tube opening has been punctured or is not visible

To open: unscrew cap, use pointed end on cap to puncture seal

To close: screw cap back onto the tube

store at 20°-25°C (68°-77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 45 g 1 Reusable Applicator Carton

Cures Most Vaginal Yeast Infections
and Relieves Associated External Itching and Irritation

NDC 68788-8989-4

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)

One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator

Educational Brochure Enclosed

MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8985(NDC:51672-2035)
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene 
Mineral Oil 
Water 
Benzoic Acid 
Packaging
#Item CodePackage Description
1NDC:68788-8985-445 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444402/01/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8985)

 
Preferred Pharmaceuticals Inc.

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Further information

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

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