Primegel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol
FDA Label NDC 81717-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Figueira E Feliciano Industria De Cosmeticos Ltda for the product Primegel Antiseptic Hand Sanitizer Gel 80 Ethyl Alcohol (NDC 81717-001). 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 drug facts, active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

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.

Other Information

  • Do not store above 104°F (40°C). 
  • Keep the container tightly closed in a cool, well-ventilated place.

Inactive Ingredients

Carbomer, glycerin, hydrogen peroxide, triethanolamine, water

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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