TOPCARE  CLOTRIMAZOLE 3- clotrimazole cream 
Topco Associates LLC

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TopCare®
Clotrimazole 3

Drug Facts

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

Use

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

Other information

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

Principal Display Panel - 21 g Tube Carton
TOPCARE   CLOTRIMAZOLE 3
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-062
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol (UNII: LKG8494WBH)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetyl esters wax (UNII: D072FFP9GU)  
octyldodecanol (UNII: 461N1O614Y)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-062-00 1 in 1 CARTON
1 21 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021143 04/12/2000
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-062)

Revised: 1/2013
Document Id: 9cf4438c-40a4-4cba-8d4d-f8f6095f38e8
Set id: 2970c5f2-282e-4b22-8e24-331c959f0e3e
Version: 1
Effective Time: 20130107
 
Topco Associates LLC