Tolnaftate
FDA Label NDC 51852-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lifelabs, A Division Of Atico International, Usa, Inc. for the product Tolnaftate (NDC 51852-102). 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 tolnaftate, otc - purpose, warnings, indications & usage, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tolnaftate

Active ingredient

Tolnaftate 1%

Otc - Purpose

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of chafing associated with jock itch
  • soothes itchy, scaly skin between the toes and itchy, burning feet

Warnings

Warnings

For external use only

Indications & Usage

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch) or 4 weeks (for athlete's foot and ringworm)

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

Dosage & Administration

Directions

  • 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 shoes 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 the scalp or nails

Storage And Handling

Other information

store between 2o and 30oC (36o and 86oF)

Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purfied water, sorbitan monostearate, stearyl alcohol

Otc - Questions

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30PM.

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