NDC 58503-045 Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower

Benzalkonium Chloride

NDC Product Code 58503-045

NDC CODE: 58503-045

Proprietary Name: Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower 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

  • 58503 - China Ningbo Shangge Cosmetic Technology Corp
    • 58503-045 - Xtracare Foam Antibacterial Hand Wash

NDC 58503-045-01

Package Description: 444 g in 1 BOTTLE

NDC Product Information

Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower with NDC 58503-045 is a a human over the counter drug product labeled by China Ningbo Shangge Cosmetic Technology Corp. The generic name of Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1233282.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower 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)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • 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: China Ningbo Shangge Cosmetic Technology Corp
Labeler Code: 58503
FDA Application Number: part333A 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: 01-24-2014 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".

* Please review the disclaimer below.

Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower Product Label Images

Xtracare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower 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

Otc - Active Ingredient

Active Ingredient                                    PurposeBenzalkonium Chloride 0.1% ............. Antibacterial

Otc - Purpose

Usesfor hand washing to decrease bacteria on the skin

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.

Indications & Usage

XtraCare® Foam Antibacterial HAnd WashKills 99.9% of bacteriaRefillCompare to Lysol foam antibacterial hand washvanilla passion flower15 Fl Oz (444mL)


WarningsFor external use onlyWhen using this product avoid contact with eyes. In case of eye contact, flush with water.Stop use and ask a doctor if irritation and redness develops.

Dosage & Administration

  • Directionspump into handslather vigorously for at least 15 secondsrinse hands with water

Inactive Ingredient

Inactive Ingredientswater, glycerin, lauramine oxide, PEG-150 distearate, cetrimonium chloride, propylene glycol, fragrance, citric acid, tetrasodium EDTA, cocamide MEA, methylchloroisothiazolinone, methylisothiazolinone, D&C red no.33, FD&C blue no.1

Other Safety Information

Other Informationstore at room temperatureQuestions/Comments? 1-855-345-5575*this product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Lysol® foam antibacterial hand wash.DISTRIBUTED BY: REJOICE INTERNATIONAL INCNORTHVILLE, MI 48168, USAMADE IN CHINA

* Please review the disclaimer below.