Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 668788-8491-4 Clotrimazole Vaginal Cream, USP 1% Vaginal Antifungal (with 1 Reusable Applicator) Cures most vaginal yeast infections 7-day therapy / 7-day treatment Educational pamphlet enclosed Net wt. 1.59 oz (45 g) tube 7 day vaginal cream with 1 reusable applicator H 2 pharma Relabeled By: Preferred Pharmaceuticals Inc. Clotrimazole 7 Day Vaginal Cream
- PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 668788-8491-4 Clotrimazole Vaginal Cream, USP 1% Vaginal Antifungal (with 1 Reusable Applicator) Cures most vaginal yeast infections 7-day therapy / 7-day treatment Educational pamphlet enclosed Net wt. 1.59 oz (45 g) tube 7 day vaginal cream with 1 reusable applicator H 2 pharma Relabeled By: Preferred Pharmaceuticals Inc. Clotrimazole 7 Day Vaginal Cream
Overview
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Indications & Usage
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Dosage & Administration
Directions • before using this product, read the enclosed educational brochure for complete directions and information • adults and children 12 years of age and over: o vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. o 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
Warnings & Precautions
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.
Purpose
Active ingredients Purpose Clotrimazole USP, 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP, 1% (external cream) Vaginal antifungal
Do Not Use
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
When Using
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 & Ask a Doctor
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
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Storage & Handling
Other information • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use • do not use if foil seal on tube opening is broken or missing • do not purchase if carton is open • store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) • before using any medication, read all label directions. Keep carton, it contains important information.
Questions
Questions? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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