NDC 51532-4604 Afassco Instant Hand Sanitizer
Ethyl Alcohol Gel Topical

Product Information

Product Code51532-4604
Proprietary Name 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.
Afassco Instant Hand Sanitizer
Non-Proprietary Name 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.
Ethyl Alcohol
Product Type 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.
Human Otc Drug
Dosage FormGel - 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.
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.
Afassco Inc.
Labeler Code51532
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-25-2018
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 51532-4604-2

Package Description: 25 POUCH in 1 BOX > 2 g in 1 POUCH

Product Details

Afassco Instant Hand Sanitizer is a human over the counter drug product labeled by Afassco Inc.. The generic name of Afassco Instant Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.


What are Afassco Instant Hand Sanitizer Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)


* Please review the disclaimer below.

Afassco Instant Hand Sanitizer Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Otc - Active Ingredient



Active Ingredient

Ethyl Alcohol  62%


Otc - Purpose



Purpose .....Antiseptic


Indications & Usage



Use:  For handwashing to decrease bacteria on skin without soap and water


Warnings



Warnings: For external use only


Other Safety Information



Drug Facts: Flammable, keep away from fire or flame. 


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. 

Do not use in eyes, if this happens, rinse thoroughly with water.


Otc - Stop Use



Stop use and ask a doctor if irritation develops and persists or 72 hours.  If

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


Dosage & Administration



Directions:

wet hands and wrists thoroughly with product and allow to dry without wiping.


Inactive Ingredient



Inactive Ingredients: Purified water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine,

Tocopherol Acetate, Aloe Vera Extract, Fragrance


Principal Display Panel



Afassco¦ ¦®​​​​    The First Choice

                              In First Aid

INSTANT HAND

SANITIZER

WITH ALOE

USE AS A HAND SANITIZER AND MOISTURIZER

FOR MAXIMUM PROTECTION

No. 604              25 ct.

Afassco¦ ¦®

The First Choice in First Aid

REMOVE TOP FOR EASY ACCESS

INSTANT HAND

SANITIZER

WITH ALOE

Compare to

Purell


USE AS A HAND SANITIZER AND MOISTURIZER

FOR MAXIMUM PROTECTION

No. 604 25 ct.

Afassco¦ ¦®

The First Choice in First Aid

INSTANT HAND

SANITIZER

WITH ALOE

Desinfectante para las manos

INSTRUCCIONES: Aplique el sanitizer

de mano a las manos y munecas.

Permite el producto para secar.

Mantenga fuera del alcante de ninos.

USE AS A HAND SANITIZER AND MOISTURIZER

FOR MAXIMUM PROTECTION

No. 604        25 ct.

INSTANT HAND

SANITIZER

WITH ALOE

USE AS A HAND SANITIZER AND MOISTURIZER

FOR MAXIMUM PROTECTION

No. 604                         25 ct.

Afassco¦ ¦® The First Choice

                         In First Aid

Afassco¦ ¦® Manufactured for Afassco, Inc., Minden, NV 89423

6 70254 60412 7

↓Inner Packet↓

  Instant hand Sanitizer by Afassco, Inc.

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* Please review the disclaimer below.