NDC 78287-250 Justhuman 24 Hour Protection Foam Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 78287-250

NDC 78287-250-01

Package Description: .06 kg in 1 BOTTLE, PUMP

NDC 78287-250-02

Package Description: .12 kg in 1 BOTTLE, PUMP

NDC 78287-250-03

Package Description: .24 kg in 1 BOTTLE, PUMP

NDC 78287-250-04

Package Description: .01 kg in 1 PACKET

NDC Product Information

Justhuman 24 Hour Protection Foam Hand Sanitizer with NDC 78287-250 is a a human over the counter drug product labeled by Swanrose Inc.. The generic name of Justhuman 24 Hour Protection Foam Hand Sanitizer is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Swanrose Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Justhuman 24 Hour Protection Foam 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.

Product Labeler Information

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

Labeler Name: Swanrose Inc.
Labeler Code: 78287
FDA Application Number: part333A 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: 12-18-2020 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.

Justhuman 24 Hour Protection Foam 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

Active Ingredient

Benzalkonium Chloride 0.13%............................Antiseptic




For handwashing to decrease bacteria on the skin that can potentially cause disease. Recommended for repeated use.



When Using Ths Product:

  • Avoid contact with the eyes. In case of eye contact, flush eyes with water.

Stop Use And Ask A Doctor If:

  • Rash or irritation develops and lasts more than 24 hrs.

Keep Out Of Reach Of Children:

  • If swallowed, get medical help or contact a Poison Control Center immediately.


  • Apply liberally to the hands and gently rub until dry. Just Human Hand Sanitizer will remain active on hands up to 24 hours - even after normal activity and washing hands.

Inactive Ingredients:

Fragrance, Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Water

Other Information:

Store at temperature 68°F to 86°F (20° to 30°C)Advanced Antiseptic \ Skin Freindly \ Alcohol-Free Hand Sanitizer

For Questions:

Call +1(323-868-3394

* Please review the disclaimer below.