NDC 50021-011 Hand Sanitizer Zytec Germ Buster

Alcohol 70%v/v Aerosol Gel

NDC Product Code 50021-011

NDC 50021-011-01

Package Description: 100 mL in 1 CAN

NDC 50021-011-02

Package Description: 300 mL in 1 CAN

NDC Product Information

Hand Sanitizer Zytec Germ Buster with NDC 50021-011 is a a human over the counter drug product labeled by Empack Spraytech Inc.. The generic name of Hand Sanitizer Zytec Germ Buster is alcohol 70%v/v aerosol gel. The product's dosage form is aerosol and is administered via topical form.

Labeler Name: Empack Spraytech Inc.

Dosage Form: Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hand Sanitizer Zytec Germ Buster Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 70 mL/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 940 (UNII: 4Q93RCW27E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Empack Spraytech Inc.
Labeler Code: 50021
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hand Sanitizer Zytec Germ Buster Product Label Images

Hand Sanitizer Zytec Germ Buster Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (V/V )

Ethyl Alcohol 70%




Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap andwater are not available


For external use only. Flammable. Keep away from fire or flame. Contents under pressure. Do not place in hot water or near radiator, stove or other spurces og heat.Do not puncture or incinerae container.

Otc - Do Not Use

  • Do not use in children less than 2 months ageon 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.


  • Adults and children over 2 yearsFor occasional and personal domestic usePlace enough product on hands to cover all surfaces. Rub hands together until drySupervise 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)Avoid freezing and extrensive heat avbove 40C (104F)Do not reuse contaner, dispose of properly

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Aqua (Water), Carbomer, Glycerin, lsopropyl Alcohol, lsopropyl Myristate, Parfum (Fragrance), Polysorbate 20, Propylene Glycol, Tocopheryl Acetate (Vitamin E), Blue 1, Red 40, Yellow 5

Questions ?

1-866-923-2665Manufactured in Canada by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

* Please review the disclaimer below.