Paroli Antibacterial Hand Sanitizer
FDA Label NDC 81161-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Paroli Solutions, S.a. De C.v. for the product Paroli Antibacterial Hand Sanitizer (NDC 81161-004). 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 ingredients, purpose, use:, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use:

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

Warnings

For external use only. Flammable. Keep away from fire or 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.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

Inactive Ingredients

glycerin, carbopol, triethanolamine, puified water USP.

* Please review the disclaimer below.