Foaming Alcohol Hand Sanitizer Liquid
FDA Label NDC 63900-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Simoniz Usa, Inc for the product Foaming Alcohol Hand Sanitizer (NDC 63900-002). 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, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

​Active Ingredient

Ethyl Alcohol 62% (v/v)

​Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

  • For external use only. Keep out of eyes, ears or mouth.

Otc - Stop Use

  • Discontinue use if irritation occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

    • FLAMMABLE.  KEEP AWAY FROM FIRE OR FLAME

Directions

  • If hands are visibily soiled, wash with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Other Information

  • Store between 59-86°F (15-30°C)
  • Avoid freezing and excessive heat above 104°F (40°C)

Inactive Ingredients

glycereth-2-cocoate, DEA-C8-18 Perfluroalkylethyl Phosphate, water.

Package Labeling:

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