NDC 13302-457 Qs Plus Instant Hand Sanitizer

Benzealkonium Chloride

NDC Product Code 13302-457

NDC 13302-457-10

Package Description: 1000 mL in 1 CARTRIDGE

NDC 13302-457-12

Package Description: 1000 mL in 1 BAG

NDC 13302-457-13

Package Description: 800 mL in 1 BAG

NDC 13302-457-16

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 13302-457-17

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC 13302-457-18

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 13302-457-27

Package Description: 800 mL in 1 CARTRIDGE

NDC Product Information

Qs Plus Instant Hand Sanitizer with NDC 13302-457 is a a human over the counter drug product labeled by Romaine Companies. The generic name of Qs Plus Instant Hand Sanitizer is benzealkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Romaine Companies

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Qs Plus Instant Hand Sanitizer 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.


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)

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: Romaine Companies
Labeler Code: 13302
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: 07-02-2019 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: 12-31-2020 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.

Qs Plus Instant Hand Sanitizer Product Label Images

Qs Plus Instant Hand Sanitizer 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

Drug Facts Box Otc-Active Ingredient Section

Benzalkonium chloride USP 0.13%

Drug Facts Box Otc-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box Otc-Warnings Section

For external use only

Drug Facts Box Otc-Purpose Section


Drug Facts Box-Otc When Using Section

Do not get into eyesif contact occurs, rinse eyes thoroughly with water

Drug Facts Box-Otc Stop Use Section

Irritation and redness develop

Drug Facts Box-Otc Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box-Otc Dosage & Administration Section

Press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your handrub hands together until drywash hands with soap and water at earliest opportunity

Drug Facts Box-Otc Inactive Ingredient Section

Water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

Qs Plus Instant Hand Sanitizer

QS Plus Instant Hand Sanitizer

* Please review the disclaimer below.