FDA Label for Miconazole 3 Combination Pack
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Miconazole 3 Combination Pack Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health (leader) 37205. 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.
Active Ingredients
Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)
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
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.
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:
- suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator after each use.
- external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
Other Information
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at room temperature 15°-30°C (59°-86°F). Avoid heat (over 30°C - 86°F)
Inactive Ingredients
- suppository: hydrogenated vegetable oil
- external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Principal Display Panel
NDC 37205-589-03
LEADER®
3 DAY TREATMENT
Reusable Applicator
VAGINAL SUPPOSITORIES plus CREAM for EXTERNAL RELIEF
Compare to
Monistat® 3
active ingredient*
Miconazole 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 mg and
Miconazole Nitrate External Vulvar Cream, 2%
VAGINAL ANTIFUNGAL
Cures most vaginal yeast infections
Relieves associated external itching and irritation
3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg plus
1 tube of Miconazole Nitrate External Vulvar Cream - NET WT 0.32 oz (9 g)
* Please review the disclaimer below.