FDA Label for Clotrimazole

Active Ingredients

Clotrimazole 1% (50 mg in each applicatorful)

Clotrimazole 1% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

• treats vaginal yeast infections
• relieves external itching and irritation associated due to a vaginal yeast infection

Warnings

For vaginal use only

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

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 - 28 G Tube Label

Austin's Health & Human Services Dept.

Clotrimazole
1%
TOPICAL
Cream

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole 1% TOPICAL Cream 30g NDC 76413-327-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
PERRIGO

Federal law prohibts the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 28 g Tube Label - clotrimazole 01