NDC 71489-008 Saniluxe Hand Sanitizer Alcohol Free

Benzalkonium Chloride

NDC Product Code 71489-008

NDC Code: 71489-008

Proprietary Name: Saniluxe Hand Sanitizer Alcohol Free 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.

Non-Proprietary Name: Benzalkonium Chloride 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.

NDC Code Structure

  • 71489 - Celeste Industries Corporation
    • 71489-008 - Saniluxe Hand Sanitizer Alcohol Free

NDC 71489-008-01

Package Description: 284 mL in 1 BOTTLE, PUMP

NDC Product Information

Saniluxe Hand Sanitizer Alcohol Free with NDC 71489-008 is a a human over the counter drug product labeled by Celeste Industries Corporation. The generic name of Saniluxe Hand Sanitizer Alcohol Free is benzalkonium chloride. The product's dosage form is gel and is administered via cutaneous form.

Labeler Name: Celeste Industries Corporation

Dosage Form: Gel - 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.

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.

Saniluxe Hand Sanitizer Alcohol Free 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 1 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)
  • TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Celeste Industries Corporation
Labeler Code: 71489
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: 02-19-2019 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: 12-31-2020 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.

Saniluxe Hand Sanitizer Alcohol Free Product Label Images

Saniluxe Hand Sanitizer Alcohol Free 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

Other

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

  • Recommended for repeated useFor hand sanitizing to decrease bacteria on the skin

Warnings

  • For external use only.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Otc - When Using

  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Pump a small amount of gel into palm of handRub hands together briskly until dryRub thoroughly over all surfaces of both hands

Inactive Ingredients

Water (Aqua), Triethylene Glycol, Glycereth-26, Cocamidopropyl PG-Dimonium Cloride Phosphate,Hydroxyethylcellulose, DMDM Hydantoin, Triethanolamine, Fragrance (Aroma), Iodopropynyl Butyl Carbamate, 1, 3-Butanediol

* Please review the disclaimer below.

Previous Code
71489-007
Next Code
71490-001