CLOTRIMAZOLE- clotrimazole cream 
McKesson

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02200711D1/ sunmark
VC101555
Clotrimazole
Vaginal Cream USP 1%
Vaginal Antifungal

Drug Facts

Active Ingredient

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

Purposes

Vaginal antifungal/external vulvar antifungal

Uses

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

Warnings

For vaginal or external vulvar use only

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.

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 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.

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

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)

sunmark-clotri label1
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-793
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-793-76 1 in 1 CARTON
1 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 07/19/1993
Labeler - McKesson (177667227)

Revised: 11/2013
Document Id: 430f18b7-1b1c-44c5-a346-be4665430e82
Set id: de3b6b64-dfa5-4abd-ba43-4ab59b4c2284
Version: 2
Effective Time: 20131105
 
McKesson