Miconazole 7
Miconazole 7
edaca770-bc76-4ac2-bad2-cf8e7de0c682
HUMAN OTC DRUG LABEL
May 27, 2025
TARGET Corporation
DUNS: 006961700
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
up&up ™
NDC 11673-049-06
7 DISPOSABLE APPLICATORS
7-DAY VAGINAL CREAM
Compare to active ingredient in Monistat ®7*
7-day treatment
miconazole 7
miconazole nitrate vaginal cream USP (2%)
(miconazole nitrate 100 mg per application)
vaginal antifungal
cures most vaginal yeast infections and relieves
associated external itching and irritation
7-day vaginal cream with disposable applicators
educational brochure enclosed
NET WT 1.5 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS
INDICATIONS & USAGE SECTION
Use
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
SPL UNCLASSIFIED SECTION
Distributed by Target Corporation
Minneapolis, MN 55403
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Miconazole Nitrate USP 2% (100 mg in each applicatorful)
OTC - PURPOSE SECTION
Purpose
Vaginal antifungal
OTC - QUESTIONS SECTION
Questions?
Call 1-800-910-6874
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 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:
***applicators:**insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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
**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 INGREDIENT SECTION
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