TOPCARE  ANTIFUNGAL- clotrimazole cream 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by 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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TopCare®
Antifungal Cream

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

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 (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

QUESTIONS?

1-888-423-0139
topcare@topco.com

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TopCare®

CURES MOST ATHLETE'S FOOT

Antifungal Cream

CLOTRIMAZOLE CREAM USP, 1%

QUALITY
GUARANTEED

COMPARE TO
LOTRIMIN® AF
active ingredient*

NET WT 0.5 OZ (14.2 g)

Principal Display Panel - 14.2 g Tube Carton
TOPCARE   ANTIFUNGAL
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-495
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 10 mg  in 1 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:36800-495-69 1 in 1 CARTON
1 14.2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 08/31/1993
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(36800-495)

Revised: 1/2013
Document Id: 5ea9c208-ef94-4854-89d9-a4b72acf51ca
Set id: 6757eb2a-73e0-4bd0-a332-5713fdf3445d
Version: 1
Effective Time: 20130108
 
Topco Associates LLC