FDA Label for Miconazole 3
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF:
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 25 G TUBE CARTON
Miconazole 3 Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. by Target Corp., Mpls., MN 55403
Active Ingredient
Miconazole nitrate USP 4%
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 (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:
- insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.
Throw applicator away after use.
- insert 1 applicatorful into the vagina at bedtime for 3 nights in a row.
- children under 12 years of age: ask a doctor
Other Information
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20° to 25°C (68° to 77°F)
- see end flaps of carton and end of tube for lot number and expiration date
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
NDC 11673-391-06
Compare to the active ingredient in Monistat® 3*
up&up
3-day treatment
miconazole 3
miconazole nitrate vaginal cream USP (4%)
vaginal antifungal
cures most vaginal yeast infections
ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE APPLICATORS
* Please review the disclaimer below.