First Aid Antifungal Medicated
FDA Label NDC 47046-164

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd for the product First Aid Antifungal Medicated (NDC 47046-164). 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 active ingredient, purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

For external use only

Otc - When Using

When using this product avoid contact with the eyes

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.

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice 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 shoes and change 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 scalps or nails

Other Information

  • store between 20 to 25°C (68 to 77°F)
  • Lot No & Expiration Date: See box or see crimp

Inactive Ingredients

petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.

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