Foaming Hand Sanitizer Solution
FDA Label NDC 50021-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Empack Spraytech Inc. for the product Foaming Hand Sanitizer (NDC 50021-020). 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, uses, warnings, do not use, otc - when using, otc - stop use, otc - 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)

Ethanol 70% (v/v)

Purpose

Antiseptic

Uses

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

Warnings

For external use only. Flammability warning. Keep away from open flame and sources of heat.

Do Not Use

  • on children less than 2 months of age
  • on open skin wounds

Otc - When Using

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. 

Otc - Stop Use

Stop use and ask a doctor if irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Topical. If swallowed, call a poison control centre or get medical help right away.

Directions

  • Adults and children over 2 years 
  • For occasional and personal domestic use 
  • Supervise children under 6 years of age when using this product to avoid swallowing 
  • Place enough product on hands to cover all surfaces. Rub hands together for at least 30 seconds until dry.

Other Information

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

Inactive Ingredients

Water, Bis-PEG-12 Dimethicone, Glycerin, Aloe Barbadensis Leaf Juice

Questions?

1-866-923-2665

Other

UPC

Manufactured by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, Canada L6T 4H6

www.zytecgermbuster.ca

Made in Canada

Lot # and Expiry Date to be embossed on the bottle

Package Label - Principal Display Panel

550 ml; NDC 50021-020-01

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