First Aid Antifungal Medicated Cream 1oz
FDA Label NDC 75983-537

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Reserach Corp for the product First Aid Antifungal Medicated Cream 1oz (NDC 75983-537). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, dosage & administration, 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

Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Helps preent most athlete's foot with daily use

for effective relief of itching, burning and cracking

Warnings

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation becomes severe
  • 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

  • wash affected area and dry throughly
  • apply a thin layer over affected area twie daily (morning and night)
  • 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
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other Safety Information

Other information

store between 20° to 25° (68° to 77°F)

Lot No. & Exp. Date;see box or see crimp of tube

Inactive Ingredient

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

Dosage & Administration

Distributed by:

First Aid Research Corp.

Wantagh, NY U.S. A. 11793

Made in Korea

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