NDC 82217-720 Gmhs, Llc Hand Sanitizer
Isopropyl Alcohol Gel Topical

Product Information

What is NDC 82217-720?

The NDC code 82217-720 is assigned by the FDA to the product Gmhs, Llc Hand Sanitizer which is a human over the counter drug product labeled by Global Medical And Health Services, Llc. The generic name of Gmhs, Llc Hand Sanitizer is isopropyl alcohol. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 82217-720-01 500 ml in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code82217-720
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.		Gmhs, Llc 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.		Isopropyl 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.		Global Medical And Health Services, Llc
Labeler Code82217
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.		part333A
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.		03-02-2023
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.		12-31-2024
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

What are the uses for Gmhs, Llc Hand Sanitizer?


Product Packages

NDC Code 82217-720-01

Package Description: 500 mL in 1 TUBE

Product Details

What are Gmhs, Llc Hand Sanitizer Active Ingredients?

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.

Gmhs, Llc Hand Sanitizer Active Ingredients UNII Codes

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Gmhs, Llc Hand Sanitizer Inactive Ingredients UNII Codes

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.

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Gmhs, Llc Hand Sanitizer Product Label

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.

Product Label Table of Contents



Drugs Facts




Active Ingredient[S]:



Isopropyl alcohol 75% v/v


Purpose:



Antiseptic


Use:



Hand sanitizer to reduce disease causing germs including cold & flu viruses


Warnings:



For external use only. Flammable. Keep away from heat, fire, or flame.

Caution: Avoid contact with eye(s). In case of accidental ingestion, seek professional assistance or contact the Poison Control Center immediately.


Otc - Keep Out Of Reach Of Children



Keep out of reach from children.


Directions:



Apply a palmful of GMHS, LLC Hand Sanitizer Gel and cover all surfaces of the hand. Rub hands until dry.


Other Information:



- Store between 15° - 30°C (59°-86°F).

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


Inactive Ingredients:



Glycerin, aloe vera 100%, purified water USP


Packaging



GMHS-720 - 8221772001

GMHS-720 - 8221772001


* Please review the disclaimer below.