Prestige Soap
FDA Label NDC 63621-335

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunburst Chemicals, Inc. for the product Prestige (NDC 63621-335). 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, use, warnings, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Chloroxylenol 1% w/w

Purpose

Skin Antimicrobial

Use

Reduces amount of bacteria on hands

Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under six months of age.

For institutional and professional use only.

Directions

  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

* Please review the disclaimer below.