Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
NDC Package 53462-009-24

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.

Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System is before opening, turn package over, burst solution packet with thumbs. Marketed by Sage Products, Llc, this product is identified by NDC 53462-009 and is authorized under FDA application NDA021669.

Identification & Billing

NDC Package Code
53462-009-24
Package Description
1 KIT in 1 KIT * 7 mL in 1 PACKET (53462-375-60) * 6 PACKAGE in 1 KIT / 6 CLOTH in 1 PACKAGE (53462-705-23)
Product Code
53462-009
11-Digit Billing Format
53462000924
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
Dosage Form
-
Usage Information
Before opening, turn package over, burst solution packet with thumbs. Peel lid to open.Brush teeth and oral cavity for approximately one minute.Instruct to expectorate.Use Applicator Swab for additional cleansing as needed.Discard after use.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 yeras of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity. use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.do not microwaveproduct and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.To open packageholding top of package in one hand, lift flap on backside of package with other handgrasp flap at top and pull down to tear flap away and expose foamhold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.Orusing sterile scissors, cut off end seal of packagetransfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contaminationuse first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm² area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm² area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. discard each cloth after a single useafter package has been opened discard any unused cloths

Regulatory & Marketing

Labeler Name
Sage Products, Llc
FDA Application #
NDA021669
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-28-2016
Listing Expiration
12-31-2020
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 53462-009-24 identifies a specific commercial package of 1 kit in 1 kit * 7 ml in 1 packet (53462-375-60) * 6 package in 1 kit / 6 cloth in 1 package (53462-705-23) of Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System, labeled by Sage Products, Llc. 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 Sage Products, Llc on December 28, 2016. The current certification is valid through December 31, 2020.

How is this Sage Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462000924. 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 (5-3-2)
53462-009-24
11-Digit CMS (5-4-2)
53462-0009-24

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