Label: CLOTRIMAZOLE- clotrimazole cream
- NDC Code(s): 0363-0220-63
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 9, 2016
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each applicatorful)
Clotrimazole, USP 50 mg (1%)Close
Vaginal antifungal/external vulvar antifungalClose
- treats vaginal yeast (candida) infections
- relieves external vulvar itching and irritation associated with a yeast infection
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.
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.
Keep out of reach of children.
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.
- 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 monostearateClose
1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.Close
- Principal Display Panel
Well at Walgreens
WALGREENS PHARMACIST RECOMMENDED
Vaginal Cream, USP 1%
- 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)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0220 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 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:0363-0220-63 1 in 1 CARTON 1 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074165 09/01/1998 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Encube Ethicals Pvt. Ltd 725076298 MANUFACTURE(0363-0220) Establishment Name Address ID/FEI Business Operations G&W NC Laboratories, LLC 079419931 MANUFACTURE(0363-0220)