NDC 79978-009 Botanika Australia Aloe Vera Anti Bacterial Hand Sanitizer

Alcohol

NDC Product Code 79978-009

NDC CODE: 79978-009

Proprietary Name: Botanika Australia Aloe Vera Anti Bacterial 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: Alcohol 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

  • 79978 - Cognescenti Pty. Ltd.
    • 79978-009 - Botanika Australia Aloe Vera Anti Bacterial Hand Sanitizer

NDC 79978-009-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Botanika Australia Aloe Vera Anti Bacterial Hand Sanitizer with NDC 79978-009 is a a human over the counter drug product labeled by Cognescenti Pty. Ltd.. The generic name of Botanika Australia Aloe Vera Anti Bacterial Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Cognescenti Pty. Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Botanika Australia Aloe Vera Anti Bacterial 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.

  • ALCOHOL 75 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)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CITRAL (UNII: T7EU0O9VPP)

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: Cognescenti Pty. Ltd.
Labeler Code: 79978
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: 08-28-2020 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.

Botanika Australia Aloe Vera Anti Bacterial Hand Sanitizer Product Label Images

Botanika Australia Aloe Vera Anti Bacterial 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

SD Alcohol 40-B 75% v/v

Purpose

Antiseptic

Use

  • Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.Flammable. Keep away from fire and flame.

When Using This Product

Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

  • Irritation and redness develops.

Keep Out Of Reach Of Children.

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

Directions

  • Put enough on you palm to cover hands. Rub hands together briskly until dry.Children under 6 years of age should be supervised when using this product.Other information:Store at 20℃ to 25℃ (68℉ to 77℉).May discolor some fabrics or surface.

Inactive Ingredients

Purified Water (Aqua), Cross Polymer, Triethanolamine, Parfum (Fragrance), Citronellol, Linalool, Lilial, Benzyl Salicylate, Hexyl Cinnamic Aldehyde, Ceranil, Cumarin, Hydroxycitronellal, Amyl Cinnamic Aldehyde, Eugenol Cinnamyl Alcohol, Eugenol Cinnamyl Alcohol, Methyl Ionone, Benzyl Benzoate, Benzyl Alcohol, Citral, Iso Eugenol, Limonene

* Please review the disclaimer below.