Hy-gn Quality Hand And Surface Sanitizers
FDA Label NDC 76972-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Telecom Holdings Llc Dba Hy-gn Llc for the product Hy-gn Quality Hand And Surface Sanitizers (NDC 76972-001). 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, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Uses

Use on hands and surfaces as a disinfecting agents to kill viruses and bacteria

Warnings

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

H226 Flammable liquid and vapour.

H319 Causes serious eye irritation.

DO NOT USE on children under the age of 2 months old or open skin wounds

WHEN USING THIS PRODUCT Keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water

STOP USE AND ASK A DOCTOR If irritation or rash occur. This may be a sign of a serious condition.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN If swallowed, seek medical help or contact Poison Control Center right away.

Directions

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

Other Information:
Store between 15-30C (59-85F)
Avoid Freezing and excessive heat above 40C (104F)

Inactive Ingredients

Deionized Water, Glycerin, Hydrogen Peroxide

Package Label - Principal Display Panel

Product label

Label1 (Drug Facts Sheet)

Label1 (Drug Facts Sheet)

Label2 (Label Front And Back)

Label2 (Label Front And Back)

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