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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
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- 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 LABEL Item Code (Source) NDC:0363-0220 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 1 g in 100 g 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 NDC:0363-0220-63 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 09/01/1998 Labeler - Walgreen Company (008965063)