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
ANDA072641
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 sorbitan monostearate
Strengths
1 % 50 mg
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
G07GZ97H65
Packaging

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Cures Most Vaginal Yeast Infections 7 Day Treatment 7 Day Vaginal Cream Clotrimazole Vaginal Cream USP (1%) Vaginal Antifungal NDC 68788-9665-4 One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%) & 1 Reusable Applicator Educational Brochure Enclosed Clotrimazole 7 Vaginal Cream

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Cures Most Vaginal Yeast Infections 7 Day Treatment 7 Day Vaginal Cream Clotrimazole Vaginal Cream USP (1%) Vaginal Antifungal NDC 68788-9665-4 One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%) & 1 Reusable Applicator Educational Brochure Enclosed Clotrimazole 7 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 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 right away.

Storage & Handling

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

Questions

Questions or comments? call 1-866-923-4914


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