Clotrimazole

Taro Pharmaceuticals U.S.A., Inc.

Clotrimazole

FULL PRESCRIBING INFORMATION: CONTENTS*

• Use
• Warnings
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Clotrimazole Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Use

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

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.

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 3 days in a row. Throw applicator away after 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

Clotrimazole 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

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate-60, purified water, and sorbitan monostearate

Questions or comments?

Call toll-free, 1-888-827-6222, for our 24 hour automated response system.

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

NDC 51672-2062-0

Cures Most Vaginal Yeast Infections

3 Day Treatment

3 Day Vaginal Cream

Clotrimazole Vaginal Cream USP (2%)
Vaginal Antifungal

One 21 g (0.74 oz) Tube Of Clotrimazole Vaginal Cream USP (2%)
& 3 Disposable Applicators

Educational Brochure Enclosed