CLOTRIMAZOLE- clotrimazole cream
Preferred Pharmaceuticals, Inc.
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Clotrimazole Vaginal Cream, USP
Uses
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- treats vaginal yeast infections
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- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only
Ask a doctor before use if you have
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- vaginal itching and discomfort for the first time
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- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
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- 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.
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- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
When using this product
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- 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).
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- do not have vaginal intercourse
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- mild increase in vaginal burning, itching or irritation may occur
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- if you do not get complete relief, ask a doctor before using another product
Directions
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- before using this product, read the enclosed educational brochure for complete directions and information
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- adults and children 12 years of age and over:
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- vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
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- 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.
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- children under 12 years of age: ask a doctor
Other information
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- store at room temperature between 2° and 30°C (36° to 86°F)
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- see end flaps of carton and tube for lot number and expiration date
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- Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.
Inactive ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
Principal Display Panel
Actavis
Relabeled by: Preferred Pharmaceuticals Inc.
NDC 68788-7682-04
Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream*
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1 Reusable Applicator (7-Day Therapy)
7-Day Treatment
One 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)
Educational Pamphlet Enclosed
| CLOTRIMAZOLE
clotrimazole cream |
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| Labeler - Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL(68788-7682) | |
Revised: 1/2024
Document Id: a8a450d3-9fcb-4b35-900f-2834ecb29a07
Set id: 37b02587-1582-49f2-88b9-5a57f3e3a242
Version: 4
Effective Time: 20240109
Preferred Pharmaceuticals, Inc.