OTC - ACTIVE INGREDIENT

(in each applicatorful)

Clotrimazole 50 mg (1%)

OTC - PURPOSE

Vaginal antifungal/external vulvar antifungal

INDICATIONS AND USAGE

• treats vaginal yeast (candida) infections
• relieves external vulvar itching and irritation associated with a yeast infection

WARNINGS

For vaginal or external vulvar use only

OTC - DO NOT USE

• if you have abdominal pain, fever or a foul-smelling vaginal discharge. Contact your doctor immediately.
• in children less than 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

• vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.
• symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection with HIV – the virus that causes AIDS). Please read enclosed educational pamphlet.

WHEN USING THIS PRODUCT

Do not use tampons

STOP USE AND ASK A DOCTOR IF

Symptoms do not get better in 3 days or infection isn’t gone in 7 days. You may have a condition other than a yeast infection.

OTC - PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

• before using this product, read the enclosed pamphlet
• fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Wash applicator after each use.
• for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.

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
• safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product

INACTIVE INGREDIENT

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

OTC - QUESTIONS

1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0220-63

Compare to the active ingredient in Gyne-Lotrimin® Vaginal Cream*

Educational Pamphlet Enclosed

Clotrimazole

VAGINAL CREAM USP 1%

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

1 Reusable Applicator (7-Day Therapy)

7-Day Treatment

ONE 45 g (1.5 OZ) Tube of Vaginal Cream and 1 Reusable Applicator (7-Day Therapy)

1 REUSABLE APPLICATOR CARTON LABEL