Your browser does not support JavaScript! CLOTRIMAZOLE CREAM [WALGREEN COMPANY]
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RxNorm Names

CLOTRIMAZOLE cream
[Walgreen Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Drug Facts

Active Ingredient (in each applicatorful)

Clotrimazole, USP 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.

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 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

Well  at Walgreens
WALGREENS PHARMACIST RECOMMENDED
7-DAY TREATMENT
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal

  • Cures most vaginal yeast infections

Educational Pamphlet Enclosed
Compare to Gyne-Lotrimin® 7
Vaginal Cream active ingredient

ONE 45 g (1.5 OZ) TUBE OF VAGINAL CREAM AND 1 REUSABLE APPLICATOR (7-DAY THERAPY)

walgreen clotrimazole label1
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0220
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 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:0363-0220-631 in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416509/01/1998
Labeler - Walgreen Company (008965063)

Revised: 11/2013
 
Walgreen Company

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