Proclearz Solution
FDA Label NDC 29784-181

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 (NDC 29784-181). 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, general precautions, when using this product, stop use and ask a doctor if, 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

Anti-fungal

Uses

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot from recurring when used daily
  • relieves itching, scaling, cracking, burning, and redness

Warnings

For external use only

  • do not use on children under 2 years of age unless directed by a doctor

General Precautions

Extremely flammable

  • keep away from fire or flame

When Using This Product

  • avoid contact with the eyes
  • if contact occurs rinse thoroughly with water

Stop Use And Ask A Doctor If

  • irritation occurs or if there is no improvement in 4 weeks

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

■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the
product over affected area (around the nails and underneath nail tips) twice daily 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. If condition
persists longer, consult a doctor ■ this product is not effective on the scalp or nails

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