Your browser does not support JavaScript! CAREONE CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [AMERICAN SALES COMPANY]
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CAREONE CLOTRIMAZOLE (clotrimazole) cream
[American Sales Company]


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 USP, 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • effectively relieves itching, cracking, burning and discomfort which can accompany these conditions

Warnings

For external use only

When using this product

  • use only as directed
  • avoid contact with the 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)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • for best results, follow directions and continue treatment for length of time indicated
  • to open, use pointed end on cap to puncture seal
  • clean skin with soap and water and dry thoroughly
  • apply a thin layer over affected area morning and evening
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitted, ventilated shoes and change shoes and socks at least once daily
  • best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist.
  • children under 12 years of age should be supervised in the use of this product
  • this product is not effective on the scalp or nails

Other information

  • store between 2-30C (36-86F)
  • do not use if seal on tube is broken or is not visible
  • see box 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

DISTRIBUTED BY
AMERICAN SALES COMPANY
4201 WALDEN AVENUE
LANCASTER, NY 14086

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

ANTIFUNGAL
CREAM

CURES MOST ATHLETE'S FOOT
CLOTRIMAZOLE CREAM USP, 1%
Relieves Itching & Burning
Greaseless, Nonstaining

NET WT 30 g (1 OZ)

Principal Display Panel - 30 g Tube Carton
CAREONE   CLOTRIMAZOLE
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-305
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:41520-305-021 in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/31/1993
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(41520-305)

Revised: 1/2013
 
American Sales Company

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