80 Ethyl Alcohol Antiseptic Hand Sanitizer
FDA Label NDC 82444-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schevaran Laboratories Private Limited for the product 80 Ethyl Alcohol Antiseptic Hand Sanitizer (NDC 82444-001). 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, use, warnings, do not use, 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.

Active Ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do Not Use

in the eyes

Stop Use And Ask A Doctor If

  • Irritation and 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.

Inactive Ingredients

Hydrogen peroxide, glycerin, FD&C Blue No. 1, fragrance

Questions? :

+1-716-430-3572

Package Labeling:

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