NDC 63148-513 Natural Concepts Non-alcohol Foaming Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 63148-513

NDC CODE: 63148-513

Proprietary Name: Natural Concepts Non-alcohol Foaming Hand Sanitizer 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

NDC 63148-513-02

Package Description: 59 mL in 1 BOTTLE, PLASTIC

NDC 63148-513-08

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 63148-513-32

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 63148-513-37

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Natural Concepts Non-alcohol Foaming Hand Sanitizer with NDC 63148-513 is a a human over the counter drug product labeled by Apollo Health And Beauty Care Inc.. The generic name of Natural Concepts Non-alcohol Foaming Hand Sanitizer is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Apollo Health And Beauty Care 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.

Natural Concepts Non-alcohol Foaming 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.

  • BENZALKONIUM CHLORIDE 1 mg/mL
  • BENZALKONIUM CHLORIDE 1 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)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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.
  • 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: Apollo Health And Beauty Care Inc.
Labeler Code: 63148
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: 07-16-2020 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.

Natural Concepts Non-alcohol Foaming Hand Sanitizer Product Label Images

Natural Concepts Non-alcohol Foaming 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 0.1%

Purpose

Antiseptic

Uses

To help decrease bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do Not Use

  • On children less than 2 months of ageon open wounds

Stop Using This Product And Ask A Doctor If

Irritation or redness develops and lasts more than 7 days.

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • Pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.children under 6 years should be supervised when using this product.

Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Polysorbate 20, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140).

* Please review the disclaimer below.