NDC 59900-119 Smart San Alcohol-free Hand Sanitizer Foam

Benzalkonium Chloride

NDC Product Code 59900-119

NDC Code: 59900-119

Proprietary Name: Smart San Alcohol-free Hand Sanitizer Foam What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 59900 - Best Sanitizers, Inc.
    • 59900-119 - Smart San Alcohol-free Hand Sanitizer Foam

NDC 59900-119-05

Package Description: 1250 mL in 1 BOTTLE

NDC 59900-119-08

Package Description: 250 mL in 1 BOTTLE

NDC 59900-119-10

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Smart San Alcohol-free Hand Sanitizer Foam with NDC 59900-119 is a a human over the counter drug product labeled by Best Sanitizers, Inc.. The generic name of Smart San Alcohol-free Hand Sanitizer Foam is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Best Sanitizers, Inc.

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.

Smart San Alcohol-free Hand Sanitizer Foam 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.

  • BENZALKONIUM CHLORIDE 1.2 mg/mL

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLOXAMER 124 (UNII: 1S66E28KXA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Best Sanitizers, Inc.
Labeler Code: 59900
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: 05-10-2019 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.

Smart San Alcohol-free Hand Sanitizer Foam Product Label Images

Smart San Alcohol-free Hand Sanitizer Foam 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

Otc - Active Ingredient

Active ingredientBenzalkonium Chloride 0.12% w/w

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • Usessanitize hands to help reduce bacteria that potentially can cause diseasehelps to prevent cross-contaminationrecommended for repeated usehelps prevent drying of skin

Warnings

  • WarningsFor external use only

Otc - When Using

  • When using this productdo not use in or near eyesuse in a well-ventilated areafor external use only

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develop.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, seek medical attention or contact Poison Control Center immediately.

Dosage & Administration

  • Directionsreceive a small amount of foam into palm of handrub thoroughly over all surfaces of both handsrub hands together until dry

Storage And Handling

Other informationstore in a cool, dry place below 104o F (40o C)

Inactive Ingredient

Inactive ingredientsWater, cocamidopropyl betaine, glycerin, poloxamer 124, phenoxyethanol, benzyl alcohol, dehydroacetic acid, sodium hydroxide, citric acid

Otc - Questions

Questions?Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4 pm PST

* Please review the disclaimer below.

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