Clotrimazole CLOTRIMAZOLE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 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 ingredient Clotrimazole USP 1% (50 mg in each applicatorful) Clotrimazole USP 1% (external cream)
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0635515990777
UNII
G07GZ97H65
Packaging

Principal display panel 7-Day Treatment Clotrimazole Vaginal Cream , USP 1% VAGINAL ANTIFUNGA L Clotrimazole Vaginal Cream Can Kill The Yeast That May Cause Vaginal Infection Cures Most Vaginal Yeast Infections g (OZ) Tube Tube of Vaginal Cream (1%) and 1 Reusable Applicator Distributed by: CDMA, Inc. Novi, MI 48375; Package label QUALITY CHOICE Vaginal Antifungal Clotrimazole, USP 1% (50 mg in each applicatorful) Clotrimazole, USP 1% (external cream)

Package Descriptions
  • Principal display panel 7-Day Treatment Clotrimazole Vaginal Cream , USP 1% VAGINAL ANTIFUNGA L Clotrimazole Vaginal Cream Can Kill The Yeast That May Cause Vaginal Infection Cures Most Vaginal Yeast Infections g (OZ) Tube Tube of Vaginal Cream (1%) and 1 Reusable Applicator Distributed by: CDMA, Inc. Novi, MI 48375
  • Package label QUALITY CHOICE Vaginal Antifungal Clotrimazole, USP 1% (50 mg in each applicatorful) Clotrimazole, USP 1% (external 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: 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

Warnings & Precautions
Warnings For external 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

Purpose Vaginal antifungal Vaginal antifungal

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.

Questions

Questions or comments? Call 1- 800-935-2362 Monday-Friday 9AM-5PM EST


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