Quality Choice Tolnaftate Antifungal
FDA Label NDC 63868-104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Tolnaftate Antifungal (NDC 63868-104). 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, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                  Purpose

Tolnaftate 1%....................................................................Antifungal

Otc - Purpose

Uses

  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • helps prevent most athlete's foot recurring when used daily
  • effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings

Warnings For external use only

Otc - When Using

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 4 weeks

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.

Indications & Usage

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 space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • 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 2° and 30° C (36° and 86° F)
  • Lot No. and Exp. Date:see box or see crimp of tube

Inactive Ingredient

Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

Dosage & Administration

Distributed By Quality Choice

Novi, Mi 48376-0995

Made in Korea

Package Label.Principal Display Panel

Image Description (Qc Tolnaftate Tb)

Image Description (Qc Tolnaftate Tb)

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