Miconazole Nitrate
Miconazole Nitrate
6b34d0be-4bcd-4dff-b732-7fbd46765019
HUMAN OTC DRUG LABEL
May 27, 2025
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation
NDC 51672-2035-6
7 Day Treatment
7 Day Vaginal Cream
Miconazole Nitrate Vaginal Cream USP (2%)
(Miconazole Nitrate 100 mg per application)
Vaginal Antifungal
One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator
Consumer Information Leaflet Enclosed
INDICATIONS & USAGE SECTION
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
SPL UNCLASSIFIED SECTION
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Miconazole nitrate USP 2% (100 mg in each applicatorful)
OTC - PURPOSE SECTION
Purpose
Vaginal antifungal
WARNINGS SECTION
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 aretaking 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.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other information
- do not purchase if carton is opened
- do not use if seal over tube opening has been punctured or is not visible
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.
OTC - QUESTIONS SECTION
Questions?
call1-866-923-4914