NDC 80742-000 Seal-d All Day Protection Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 80742-000

NDC 80742-000-00

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 80742-000-01

Package Description: 200 mL in 1 BOTTLE, PUMP

NDC Product Information

Seal-d All Day Protection Hand Sanitizer with NDC 80742-000 is a a human over the counter drug product labeled by Advanced Nanocoatings, Inc. The generic name of Seal-d All Day Protection Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Advanced Nanocoatings, 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.

Seal-d All Day Protection 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 1.3 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)
  • POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
  • C12-15 PARETH-12 (UNII: 131316X18L)
  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)

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: Advanced Nanocoatings, Inc
Labeler Code: 80742
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: 09-30-2020 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.

Seal-d All Day Protection Hand Sanitizer Product Label Images

Seal-d All Day Protection 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%

Purpose

Antiseptic Hand Sanitizer

Uses:

Hand Sanitizer to help decrease bacteria on the skin 
- Recommended for repeated use.

Warnings:

Do not freezeFor external use only

Do Not Use

In ears or mouth.

When Using This Product,

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

Stop Use And Ask A Doctor If

  • Redness or irritation develop and persist for more than 72 hours

Keep Out Of Reach Of Children.

  • Children should be supervised when using this product.

Directions:

Apply a small amount into palms and spread on both hands. Rub into skin until dry.

Inactive Ingredients:

Water, polyaminopropyl biguanide, 1-octadecanaminum nn dimethyl (3-trimethoxysily) propyl chloride, c12-15 pareth 12, caprylyl glucoside, sodium benzoate, glycerin, aloe barbadensis leaf juice extract, citric acid

* Please review the disclaimer below.