NDC 49348-477 Advanced Hand Sanitizer
Ethyl Alcohol Gel Topical

Product Information

Advanced Hand Sanitizer is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Advanced Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Product Code49348-477
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.
Advanced 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.
Strategic Sourcing Services Llc
Labeler Code49348
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.
12-17-2012
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.
12-31-2023
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 Advanced Hand Sanitizer?


Product Packages

NDC 49348-477-37

Package Description: 236 mL in 1 BOTTLE, PUMP

Price per Unit: $0.00932 per ML

Product Details

What are Advanced 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.

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:

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

* Please review the disclaimer below.

Advanced 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



Active Ingredient



Ethyl alcohol 70%


Purpose



Antiseptic


Uses



  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings



For external use only: hands only

Flammable.  Keep away from heat and flame.


When Using This Product



  • keep out of eyes.  In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop Use And Ask A Doctor If



skin irritation develops


Keep Out Of Reach Of Children.



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


Directions



  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other Information



  • do not store above 105⁰ F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive Ingredients



water, aloe, barbadensis leaf juice, glyceryl, caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5


Claims



*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds

**This product is not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Aloe Advanced Hand Sanitizer

Made in USA with US and foreign components

Another Quality Product Distributed By McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us at www.sunmarkbrand.com

439.000/439AB


Principal Display Panel



sunmark

COMPARE TO PURELL**

NDC 49348-477-37

advanced hand sanitizer

more effective formula

Kills more than 99.99% of germs*

WITH ALOE

8 FL OZ (236 mL)


* Please review the disclaimer below.