NDC 47593-462 Keystone Antibacterial

Triclosan

NDC Product Code 47593-462

NDC 47593-462-11

Package Description: 3780 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Keystone Antibacterial with NDC 47593-462 is a a human over the counter drug product labeled by Ecolab Inc.. The generic name of Keystone Antibacterial is triclosan. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 260054.

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.

Keystone Antibacterial 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.


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)
  • POTASSIUM COCOATE (UNII: F8U72V8ZXP)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • ALCOHOL (UNII: 3K9958V90M)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • BORIC ACID (UNII: R57ZHV85D4)
  • HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
  • COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: 11-11-2009 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 - NO 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".

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Keystone Antibacterial Product Label Images

Keystone Antibacterial 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

Triclosan, 0.3%

Purpose

Antiseptic handwash

Uses

  • For handwashing to decrease bacteria on the skin

Warnings

  • For external use only

When Using This Product

  • Discontinue use if irritation and redness developAvoid contact with eyes

Stop Use And Ask A Doctor If

  • Irritation, discomfort and redness persist 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 with warm waterApply handsoapRub vigorously for 20 secondsWash between fingers, around fingernails and backs of handsRinse thoroughly with warm waterDry with paper towels or air-dryUse once or twice daily as part of a daily cleaning routine

Other Information

  • For additional information, see Material Safety Data Sheet (MSDS)For emergency medical information in USA and Canada, cal 1-800-328-0026For emergency medical information worldwide, call 1-651-222-5352 (in the USA)

Inactive Ingredient

Inactive Ingredients  water, potassium cocoate, sodium laureth sulfate, SD alcohol 40-B, hexylene glycol, boric acid, hydroxyethylcellulose, cocamidopropyl PG dimonium chloride phosphate, tetrasodium EDTA, PEG 75 lanolin, lauramine oxide, fragrance, methylparaben, propylparaben, aloe barbadensis, FDC blue 1

Otc - Questions

Questions?  Call 1 800 35 CLEAN

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