Careone Cream
FDA Label NDC 41520-305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone (NDC 41520-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

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

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)

Otc - Do Not Use

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

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (30 g Tube Carton)

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