Extra Stength Hand Sanitizer Aerosol, Spray
FDA Label NDC 50021-008

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 Extra Stength Hand Sanitizer (NDC 50021-008). 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 ingredients (w/w ), purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, 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 Ingredients (W/W )

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and

water are not available

Warnings

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

Otc - Do Not Use

Do not use

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Hold can at 10 inches distance
  • Spray 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 at room temperature 15-30 C (59-86°F). May stain surfaces and fabrics.
    • Avoid freezing and extrensive heat avbove 40C (104F)

Inactive Ingredients

Water (Aqua), Isobutane, Fragrance (Parfum).

Questions ?

1-866-923-2665

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

UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

Principal Display Panel -

Extra Stength Hand Sanitizer Spray

Alcohol Antiseptic 80%

Packge size ranges between 51g (100 ml) to 252g (500 ml)

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