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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-793
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
OCTYLDODECYL STEARATE 
POLYSORBATE 60 
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-793-761 in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416507/19/1993
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