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CAREONE

American Sales Company
Taro Pharmaceuticals U.S.A., Inc.

CAREONE™ Clotrimazole USP 1%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

CAREONE 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

CAREONE 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)

CAREONE

CAREONE

Clotrimazole CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-305
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Clotrimazole CLOTRIMAZOLE 10 mg

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 30 in 1 TUBE
2 NDC:41520-305-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 1993-08-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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