7 DAY VAGINAL
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
treats repeat vaginal yeast infections
relieves external itching and irritation due to a repeat vaginal yeast infection
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 medication warfarin, because bleeding or bruising may occur.
When using this product
do not use tampons, douches, spermicides, or other vaginal products
do not have vaginal intercourse
condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
before using this product read the enclosed consumer information leaflet for complete instructions
adults and children 12 years of age and over:
- applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
- external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as needed
children under 12 years of age: ask a doctor
do not use if seal over tube opening has been punctured or cannot be seen
store at room temperature 15°-30°C (59-86°F). Avoid heat over 30°C or 86°F.
benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
PRINCIPAL DISPLAY PANEL
7 DAY VAGINAL CREAM
Miconazole NitrateVAGINAL CREAM 2% • VAGINAL ANTIFUNGAL
Cures most vaginal yeast infections.
Relieves external vulvar itching and irritation associated with a yeast infection
Compare to Monistat® 7 active ingredient*
NET WT 1.59 OZ (45 g)
DUBLIN, OH 43017
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
*This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT® 7. MONISTAT® 7 is a registered trademark of Johnson & Johnson.
|7 DAY VAGINAL
miconazole nitrate cream
|Labeler - Cardinal Health (097537435)|
|Registrant - G & W Laboratories, Inc. (001271188)|
|G & W Laboratories, Inc.||001271188||MANUFACTURE(37205-590)|