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Clotrimazole

McKesson

02200711D1/ sunmarkVC101555ClotrimazoleVaginal Cream USP 1%Vaginal Antifungal




FULL PRESCRIBING INFORMATION

Drug Facts

(in each applicatorful)
Clotrimazole 50 mg (1%)

Vaginal antifungal/external vulvar antifungal

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

For vaginal or external vulvar use only

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

• 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.

do not use tampons

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.

ask a health professional before use.

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

• 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.

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

1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.

sunmark®
COMPARE TO GYNE-LOTRIMIN® ACTIVE INGREDIENT*
NDC 49348-793-76
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal
Cures most vaginal yeast infections
EDUCATIONAL PAMPHLET ENCLOSED
ONE 45 g (1.5 OZ) TUBE OF VAGINAL CREAM
AND ONE REUSABLE APPLICATOR (7-DAY THERAPY)

Clotrimazole

Clotrimazole

Clotrimazole CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-793
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Clotrimazole CLOTRIMAZOLE 10 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECYL STEARATE
POLYSORBATE 60
water
Sodium Phosphate, Monobasic, Monohydrate
SORBITAN MONOSTEARATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 45 in 1 TUBE
2 NDC:49348-793-76 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 1993-07-19


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