Clotrimazole

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

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

Warnings

For vaginal use only

OTC - DO NOT USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:ovaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.oexternal 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

• •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, sorbitan monostearate

SPL UNCLASSIFIED SECTION

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

Relabeled By: Preferred Pharmaceuticals Inc.