NDC 72619-2020 Instant Hand Sanitizer

Instant Hand Sanitizer

NDC Product Code 72619-2020

NDC 72619-2020-1

Package Description: 56 mL in 1 BOTTLE, PLASTIC

NDC 72619-2020-2

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 72619-2020-4

Package Description: 3 mL in 1 PACKET

NDC Product Information

Instant Hand Sanitizer with NDC 72619-2020 is a a human over the counter drug product labeled by Acessory Myxx Llc. The generic name of Instant Hand Sanitizer is instant hand sanitizer. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 581660.

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.

Instant 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.


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.

  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Acessory Myxx Llc
Labeler Code: 72619
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: 05-18-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Instant 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

Instant Hand Sanitizer

Warnings


For external use only: hands


Keep out of reach of


children.If swallowed, get


medical help or contact a


Poison Control Center right


away.


Stop use and ask a doctor


if irritation and redness


develop condition persists


for more than 72 hours


aviid contact with broken


skin do not inhale or


ingest

General Warnings

Warnings


For external use only: hands


Keep out of reach of


children.If swallowed, get


medical help or contact a


Poison Control Center right


away.


Stop use and ask a doctor


if irritation and redness


develop condition persists


for more than 72 hours


aviid contact with broken


skin do not inhale or


ingest

Otc - Active Ingredient

Ethyl alcohol 70%-75%

Indications & Usage

Use to decrease bacteria on the skin. Use on hands only.

Inactive Ingredient

Water, Aloe Barbadensis Leaf Juice,


Maltodextrin,Glycerin, Propylene


Glycol, Acrylates/C10-30 Alkyl


Acrylate Crosspolymer,


Triethanoamine, Fragrance, Lactose,


Microcrystalline Cellulose,Sucrose,


Zea Mays(Corn) starch, Ultramarine


blue CI 77007,Tocopheryl Acetate,


Hydroxypropyl Methyl Cellulose,


D&C Red NO.33, FD&C Blue No.1

Otc - Purpose

To clean hands and fight bacteria on that skin

Dosage & Administration

Squeeze the bottle on your hands so the liquid comes out. Rub hands together. Allow hands to dry.

Otc - Keep Out Of Reach Of Children

Not intended for children under the age of 12. Please keep out of reach of children.

* Please review the disclaimer below.