Other
Drug Facts
Manufactured for Shopko
By Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Miconazole 3
FDA Label NDC 37012-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Miconazole 3 (NDC 37012-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each applicator), purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Applicator)
Miconazole Nitrate USP 4% (200 mg in each applicator)
Purpose
Vaginal antifungal
Use
- treats vaginal yeast infections
Warnings
For vaginal use only
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 consumer information leaflet for complete directions and information
- adults and children 12 years of age and over:
- insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.
- Throw applicator away after use.
- children under 12 years of age: ask a doctor
Other Information
- store at 20°-25°C (68°-77°F)
- do not purchase if carton is open
- see end flaps of carton and end of tube for lot number and expiration date
- the tube opening should be sealed. If seal has been broken, do not use product.
Inactive Ingredients
cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.
Questions?
Call 1-866-923-4914
Principal Display Panel - 25 G Tube Carton
SHOPKO®
Miconazole 3
Miconazole Nitrate Vaginal Cream USP (4%)
Vaginal Antifungal
(Miconazole Nitrate 200 mg Per Applicator)
3 Day Treatment
Consumer Information
Leaflet Enclosed
NDC 37012-070-09
*Compare to the active
ingredient in Monistat® 3*
One 0.9 oz (25 g) Tube of 3 Day Vaginal Cream with 3 Disposable Applicators
Principal Display Panel (25 g Tube Carton)
* Please review the disclaimer below.
