Proclearz Laser Antifungal Liquid
FDA Label NDC 29784-183

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rooftop Consumer Health, Inc for the product Proclearz Laser Antifungal (NDC 29784-183). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of itching, burning, and cracking

Warnings

For external use only.

Flammable:Do not use while smoking or near heat or flame

Do Not Use

on children under 2 years of age unless directed by a doctor.

When Using This Product

  • Avoid contact with eyes
  • Use only as directed. Intentional misuse by deliberately concetrating and inhaling contents can be harmful or fatal
  • Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F

Stop Use And Ask Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks

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
  • shake can well and spray 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, ventilated shoes and changes 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 Information

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

Inactive Ingredients

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (30% v/v)

Package Labeling:

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