Pro Clean Instant Hand Sanitizer
FDA Label NDC 80570-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sistemas De Sanitazion Y Fragancias Avanzados S.a. for the product Pro Clean Instant Hand Sanitizer (NDC 80570-001). 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[s], purpose, use[s], warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient[S]

Ethyl Alcohol 70%

Purpose

Antiseptic

Use[S]

To help reduce bacteria and germs on the skin that potentially can cuase disease. Recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from heat or flame

Do Not Use

  • in eyes, in case of contact rinse eyes thoroughly with water
  • 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.

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 20-25C (68-77F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, carbomer, triethanolamine, glycerin.

Package Labeling:29Ml

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Package Labeling:59Ml

Label2 (Label2)

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Package Labeling:236Ml

Label3 (Label3)

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Package Labeling:295Ml

Label4 (Label4)

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Package Labeling:473Ml

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