Careall Tolnaftate Cream
FDA Label NDC 51824-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Tolnaftate (NDC 51824-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Tolnaftate 1%

Otc - Purpose

Antifungal

Otc - Keep Out Of Reach Of Children

If Swallowed, get medical help or contact a Poison Control center right away.

Indications & Usage

  • Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete's foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks

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

Dosage & Administration

  •  Wash affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shows and change shoes and 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 consult a doctor
  • This product is not effective on scalp or nails

Inactive Ingredient

Propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

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