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Clotrimazole

Preferred Pharmaceuticals, Inc.

Clotrimazole Vaginal Cream




FULL PRESCRIBING INFORMATION

(in each applicatorful)

Clotrimazole 50 mg (1%)

Vaginal antifungal/external vulvar antifungal

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

For vaginal or external vulvar use only

  • if you have abdominal pain, fever or a foul-smelling vaginal discharge. Contact your doctor immediately.
  • in children less than 12 years of age
  • 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.

Do not use tampons

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.

Ask a health professional before use.

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

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday - Friday

68788-0169-4

Compare to the active ingredient in Gyne-Lotrimin® Vaginal Cream*

Educational Pamphlet Enclosed

Clotrimazole

VAGINAL CREAM USP 1%

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

1 Reusable Applicator (7-Day Therapy)

7-Day Treatment

ONE 45 g (1.5 OZ) Tube of Vaginal Cream and 1 Reusable Applicator (7-Day Therapy)

Clotrimazole

Clotrimazole

clotrimazole CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-0169(NDC:0472-0220)
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Clotrimazole CLOTRIMAZOLE 1 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 45 in 1 TUBE
2 NDC:68788-0169-4 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 2013-08-06


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Be sure to consult your doctor before taking any medication!
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