RxNorm Names
TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF
(miconazole nitrate)
cream
[Topco Associates LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d6f3e419-45f2-4acc-9c14-daead374aa72| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
Warnings
For vaginal use only
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
- if you do not get complete relief ask a doctor before using another product.
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.
PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
TopCare®
NDC 36800-070-09
3-DAY TREATMENT
Miconazole 3
MICONAZOLE NITRATE VAGINAL CREAM USP (4%)
VAGINAL ANTIFUNGAL
(MICONAZOLE NITRATE 200 mg PER APPLICATOR)
- Cures most vaginal yeast infections
QUALITY
GUARANTEED
COMPARE TO
MONISTAT® 3
active ingredient*
One 0.9 oz (25 g) tube of three-day vaginal cream
with three disposable applicators
NET WT 0.9 OZ (25 g) TUBE
Consumer information leaflet enclosed
| TOPCARE
MICONAZOLE 3 YEAST INFECTION RELIEF
miconazole nitrate cream |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(36800-070) | |
Review RxNorm Normal Forms