RxNorm Names
Review RxNorm Normal Forms
TOPCARE CLOTRIMAZOLE 3
(clotrimazole)
cream
[Topco Associates LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2970c5f2-282e-4b22-8e24-331c959f0e3e| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | New Drug Application |
Use
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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
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 enclosed educational brochure for complete directions and information
- adults and children 12 years of age and over:
- vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 3 days in a row. Throw applicator away after use.
- external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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
- To open: unscrew cap, use pointed end on cap to puncture seal
- do not use if carton is opened
- safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
- store between 20° to 25°C (68° to 77°F)
- see flap of carton or crimp of tube for lot number and expiration date
Inactive ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate-60, purified water, and sorbitan monostearate
PRINCIPAL DISPLAY PANEL - 21 g Tube Carton
TopCare®
NDC 36800-062-00
3-DAY TREATMENT
Clotrimazole 3
CLOTRIMAZOLE VAGINAL CREAM USP (2%)
VAGINAL ANTIFUNGAL
• Cures most vaginal yeast infections
QUALITY
GUARANTEED
COMPARE TO
GYNE-LOTRIMIN 3®
active ingredients*
One 21g (0.74 OZ) tube of three-day vaginal cream
with three disposable applicators
NET WT 0.74 OZ (21 g) TUBE
| TOPCARE
CLOTRIMAZOLE 3
clotrimazole 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(36800-062) | |
Revised: 01/2013
Document Id: 9cf4438c-40a4-4cba-8d4d-f8f6095f38e8
Set id: 2970c5f2-282e-4b22-8e24-331c959f0e3e
Version: 1
Effective Time: 20130107
Topco Associates LLC
