Clotrimazole Cream
FDA Label NDC 49348-793

Clotrimazole, USP 1% (50 mg in each applicatorful)

Clotrimazole, USP 1% (external cream)

Vaginal antifungal

Vaginal antifungal

• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection

For vaginal use only

if you have never had a vaginal yeast infection diagnosed by a doctor

• vaginal itching and discomfort for the first time
• lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.  You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant, or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• been exposed to the human immunodeficiency virus (HIV) that causes AIDS

• do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
• do not have vaginal intercourse
• mild increase in vaginal burning, itching or irritation may occur
• if you do not get complete relief, ask a doctor before using another product

• symptoms do not get better in 3 days
• symptoms last more than 7 days.
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge

ask a health professional before use.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

• before using this product, read the enclosed educational brochure for complete directions and information
• adults and children 12 years of age and over:
  • vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
  • external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor
    

• 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
• Tamper-evident: 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 between 9 am and 4 pm EST, Monday-Friday.

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 (1%)
AND ONE REUSABLE APPLICATOR (7-DAY THERAPY)