Sterile Isotonic Buffered Genuine Eyewash
NDC Package 52124-0005-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sterile Isotonic Buffered Genuine Eyewash is tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use. Marketed by Genuine First Aid, this product is identified by NDC 52124-0005 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
52124-0005-1
Package Description
10 mL in 1 BOTTLE
Product Code
52124-0005
11-Digit Billing Format
52124000501
RxNorm Crosswalk
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream
  • RxCUI: 1038561 - benzalkonium Cl 0.4 % Medicated Pad
  • RxCUI: 1038561 - benzalkonium chloride 4 MG/ML Medicated Pad

Clinical Specifications

Proprietary Name
Sterile Isotonic Buffered Genuine Eyewash
Dosage Form
-
Usage Information
Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use. Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage Clean intended area thoroughly with pad. Discard after single use. Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use. Adults and children 2 years of age and olderclean affected area.apply a small amount of this product on the area 1 to 3 times daily.may be covered with a sterile bandagechildren under 2 years of age: consult a doctor do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.Children under 12 years: Do not give to children under 12 years of age. do not use more than directedthe smallest effective dose should be useddrink a full glass of water with each dosedo not take longer than 10 days, unless directed by a doctor Wipe Injection site vigorously and discard. Clean intended area thoroughly with pad. Discard after single use.

Regulatory & Marketing

Labeler Name
Genuine First Aid
FDA Application #
part349
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-16-2010
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52124-0005-1 identifies a specific commercial package of 10 ml in 1 bottle of Sterile Isotonic Buffered Genuine Eyewash, labeled by Genuine First Aid. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Genuine First Aid on February 16, 2010. The current certification is valid through December 31, 2017.

How is this Genuine First Aid product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52124000501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
52124-0005-1
11-Digit CMS (5-4-2)
52124-0005-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.