Offex 80% Ethyl Alcohol Sanitizer
FDA Label NDC 78608-392

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Star Valley Research, Llc Dba United Sanitizer for the product Offex 80% Ethyl Alcohol Sanitizer (NDC 78608-392). 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 drug facts, active ingredient(s), purpose, warnings, directions, other information, inactive ingredients, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient(S)

Alcohol 80% v/v

Purpose

Antiseptic

Warnings

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

Do not use

  • In children less than 2 months of age
  • On open skin wounds

    • When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

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

Other Information

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

Inactive Ingredients

  • 80% Ethyl Alcohol, hydrogen peroxide, glycerin, water. Premium blend at 80% alcohol mixed with hydrogen peroxide.

Packaging

Image Description (Label)

Image Description (Label)

* Please review the disclaimer below.