Your browser does not support JavaScript! TOPCARE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]
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TOPCARE ANTIFUNGAL (clotrimazole) cream
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-495
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetostearyl alcohol 
cetyl esters wax 
octyldodecanol 
polysorbate 60 
water 
sorbitan monostearate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-495-691 in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/31/1993
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-495)

Revised: 1/2013
 
Topco Associates LLC

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