NDC 77419-3100 Amass Basilisk Breath Sanitizer Liquid

Basilisk Breath Sanitizer Spray

NDC Product Code 77419-3100

NDC CODE: 77419-3100

Proprietary Name: Amass Basilisk Breath Sanitizer Liquid 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: Basilisk Breath Sanitizer Spray 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

  • 77419 - Amass Brands, Inc
    • 77419-3100 - Amass Basilisk Breath Sanitizer Liquid

NDC 77419-3100-1

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Amass Basilisk Breath Sanitizer Liquid with NDC 77419-3100 is a a human over the counter drug product labeled by Amass Brands, Inc. The generic name of Amass Basilisk Breath Sanitizer Liquid is basilisk breath sanitizer spray. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Amass Brands, 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.

Amass Basilisk Breath Sanitizer Liquid 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 43.66 mL/59mL

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.

  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • GLYCEROL FORMAL (UNII: 3L7GR2604E)
  • BASIL OIL (UNII: Z129UMU8LE)
  • SAGE OIL (UNII: U27K0H1H2O)
  • THYME OIL (UNII: 2UK410MY6B)
  • WATER (UNII: 059QF0KO0R)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • EUGENOL (UNII: 3T8H1794QW)

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: Amass Brands, Inc
Labeler Code: 77419
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: 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.

Amass Basilisk Breath Sanitizer Liquid 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 Ingredients ......... Purpose

70% Ethyl Alcohol (v/v)........ Antiseptic

Otc - Do Not Use

Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical attention or contact a poison center immediately.

Otc - Purpose

USE

Hand sanitizer to help reduce disease-causing bacteria

Otc - Stop Use

Stop use and ask a doctor if irriation or rash occurs.

Otc - When Using

Directions

Apply liberally to dry hands, rub briskly until evaporated

Children should be supervised when using this product

Other Safety Information

OTHER INFORMATION

Avoid freezing and excessive heat above 104F (40C)

Warnings And Precautions

WARNINGS

Flammable. Keep away from heat or flame.

For external use only.

Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.

Instructions For Use

DIRECTIONS

Apply liberally to dry hands, rub briskly until evaporated.

Children should be supervised when using this product

Inactive Ingredient

INACTIVE INGREDIENTSAqua, Glycerin, Ocimum Basilicum (Sweet Basil) Oil, Mentha Piperita (Peppermint) Oil, Salvia Rosmarinus (Rosemary) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil, Linalool, Eugenol

Dosage & Administration

DIRECTIONS

Apply liberally to dry hands, rub briskly until evaporated.

Children should be supervised when using this product

Warnings

WARNINGS

Flammable. Keep away from heat or flame.

For external use only.

Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.

Indications & Usage

USE

Hand sanitizer to help reduce disease-causing bacteria.

* Please review the disclaimer below.