Hand Sanitizer Gel
FDA Label NDC 11344-370

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Hand Sanitizer (NDC 11344-370). 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 and 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

  • skin irritation or redness develops
  • 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

Other Information

  • do not store above 105⁰ F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive Ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

Other

Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds*

This product is not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer**

Manufactured By: Vi-Jon, LLC
8515 Page Ave
St. Louis, MO 63114

370.000/370AB

Principal Display Panel

germ-X

since 1997

ADVANCED

KILLS MORE THAN 99.99% OF GERMS

moisturizing

HAND SANITIZER

USP GRADE ALCOHOL

Formulated for Healthcare Workers

FORMULA MADE IN USA EMPLOYEE-0WNED

12 FL OZ (354 mL)

Image Description (Mm4)

Image Description (Mm4)

* Please review the disclaimer below.