Sanimax Hand Sanitizer
FDA Label NDC 80289-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sanimax Llc for the product Sanimax Hand Sanitizer (NDC 80289-001). 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[s], purpose, use[s], warnings, do not use, when usin this product, stop use and ask a doctor, 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[S]

Alcohol 70% v/v

Purpose

Antiseptic

Use[S]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • in children less than 2 months of age
  • on open skin wounds

When Usin This Product

keep out of eyes, ears, and mouth. In case de of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

if irritation or rash occurs. Theses may be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hand together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

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

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

Label (Label)

Label (Label)

* Please review the disclaimer below.