Hand Sanitizer Gel
FDA Label NDC 53329-202

12 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Hand Sanitizer (NDC 53329-202). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

For external use only: hands

Flammable. keep away from heat or flame.

When Using This Product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop Use And Ask A Doctor If

  • irritation or redness develop
  • condition persists for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

    • Added in missing direction for use found on current labeling.

Other Information

  • do not store above 105°F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, diisopropylamine, glycerin, isopropyl myristate, tocopheryl acetate, water

Package Label

* Please review the disclaimer below.