NDC 47593-592 Swisher
Benzalkonium Chloride Liquid Topical

Product Information

Product Code47593-592
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.
Swisher
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.
Benzalkonium Chloride
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 FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Ecolab Inc.
Labeler Code47593
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.
06-15-2018
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 47593-592-41

Package Description: 750 mL in 1 BOTTLE, PLASTIC

Product Details

Swisher is a human over the counter drug product labeled by Ecolab Inc.. The generic name of Swisher is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.


What are Swisher 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)


* Please review the disclaimer below.

Swisher 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



Benzalkonium chloride 0.1%


Purpose



Antiseptic handwash


Uses



  • for handwashing to decrease bacteria on the skin

Warnings



For external use only

Do Not Use



  • In eyes

When Using This Product



  • If in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop

Otc - Ask Doctor



Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry

Other Information



  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Inactive Ingredient



Inactive ingredients  water (aqua), isopropoyl alcohol, propylene glycol, FD&C red 40, FD&C blue 1


Otc - Questions



Questions? call 1.866.444.7450


Principal Display Panel & Representative Label



SWISHER

HIGH PERFORMANCE HAND SANITIZER

6101905

750 mL (25 US FL OZ)

Active ingredient: 

Benzalkonium chloride 0.1%

772419/5400/0618

For more ingredient information visit: www.ecolab.com/sds

This product may be patented: www.ecolab.com/patents

For more information visit: www.swsh.com

For questions or comments, call 1-866-444-7450.

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

© 2018 Ecolab USA Inc. · All rights reserved | Made in U.S.A. 


* Please review the disclaimer below.