NDC 47593-591 Swisher

Benzalkonium Chloride

NDC Product Code 47593-591

NDC 47593-591-41

Package Description: 750 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Swisher with NDC 47593-591 is a 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 solution and is administered via topical form.

Labeler Name: Ecolab Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Swisher 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.

  • BENZALKONIUM CHLORIDE 5 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • COCAMINE OXIDE (UNII: QWA2IZI6FI)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
  • MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)
  • MYRISTAMINE OXIDE (UNII: J086PM3RRT)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)
  • ALCOHOL (UNII: 3K9958V90M)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Ecolab Inc.
Labeler Code: 47593
FDA Application Number: part333E 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: 06-20-2018 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Swisher Product Label Images

Swisher 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

Active Ingredient

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash

Uses

  • For handwashing to decrease bacteria on the skin

Warnings

For external use only

Do Not Use

  • In eyes

When Using The 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

  • Wet hands and apply foamscrub hands and forearmsrinse thoroughly and dry

Other Information

  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCTEMERGENCY HEALTH INFORMATIN: 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), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium-7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, potassium hydroxide, blue 1, methylparaben, propylparaben.

Otc - Questions

Questions? call 1.866.444.7450

* Please review the disclaimer below.