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TopCare

Topco Associates LLC
Taro Pharmaceuticals U.S.A., Inc.

TopCare Clotrimazole 3


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal Antifungal
Clotrimazole USP 2% (external cream) Vaginal Antifungal

Use

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

Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

  • 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

When using this product

  • 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

Stop use and ask a doctor if

  • 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

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 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 3 days in a row. Throw applicator away after 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

TopCare Other information

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • do not use if carton is opened
  • safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
  • store between 20° to 25°C (68° to 77°F)
  • see flap of carton or crimp of tube for lot number and expiration date

Inactive ingredients

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

Questions or comments?

Call toll-free, 1-888-423-0139 for our 24 hour automated response system.

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

TopCare®

NDC 36800-062-00

3-DAY TREATMENT

Clotrimazole 3

CLOTRIMAZOLE VAGINAL CREAM USP (2%)
VAGINAL ANTIFUNGAL

• Cures most vaginal yeast infections

QUALITY
GUARANTEED

COMPARE TO
GYNE-LOTRIMIN 3®
active ingredients*

One 21g (0.74 OZ) tube of three-day vaginal cream
with three disposable applicators

NET WT 0.74 OZ (21 g) TUBE

TopCare

TopCare

Clotrimazole CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-062
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Clotrimazole CLOTRIMAZOLE 2 g

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECANOL
POLYSORBATE 60
water
SORBITAN MONOSTEARATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 21 in 1 TUBE, WITH APPLICATOR
2 NDC:36800-062-00 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021143 2000-04-12


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Be sure to consult your doctor before taking any medication!
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