Clotrimazole: Package Insert and Label Information
CLOTRIMAZOLE- clotrimazole cream
Preferred Pharmaceuticals, Inc.
Drug Facts
Active ingredients
Clotrimazole, USP 1% (50 mg in each applicatorful)
Active ingredients
Clotrimazole, USP 1% (external cream)
Purpose
Vaginal antifungal
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
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
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 a 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 (1-800-222-1222) right away.
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 7 days in a row. Wash applicator after each 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
- •
- store at room temperature between 2° and 30°C (36° to 86°F)
- •
- see end flaps of carton and tube for lot number and expiration date
- •
- 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
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
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
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| Labeler — Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant — Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL (68788-7682) | |
Revised: 04/2021 Preferred Pharmaceuticals, Inc.
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