Clotrimazole CLOTRIMAZOLE PREFERRED PHARMACEUTICALS INC. FDA Approved Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
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Substance Clotrimazole
Route
VAGINAL
Applications
ANDA074165
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Purpose Clotrimazole USP 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP 1% (external cream) Vaginal antifungal
Inactive Ingredients
Inactive ingredients benzyl alcohol cetostearyl alcohol cetyl esters wax 2-octyldodecanol polysorbate 60 purified water sodium phosphate monobasic sorbitan monostearate
Strengths
1 % 50 mg
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
G07GZ97H65
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

Package Descriptions
  • 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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