Cardinal Health Antiseptic Skin Cleanser
NDC Package 0116-0113-16

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cardinal Health Antiseptic Skin Cleanser is use with care in premature infants or infants under 2 months of age. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-0113 and is authorized under FDA application NDA019422.

Identification & Billing

NDC Package Code
0116-0113-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0116-0113
11-Digit Billing Format
00116011316

Clinical Specifications

Proprietary Name
Cardinal Health Antiseptic Skin Cleanser
Dosage Form
-
Usage Information
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.Surgical hand scrub:wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingersrinse thoroughly under running water for 30 secondswash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 secondsdry throughlyHealthcare personnel handwash:wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 secondsrinse and dry thoroughlySkin wound and general skin cleansing:thoroughly rinse the area to be cleaned with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gentlyrinse again thoroughly

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
FDA Application #
NDA019422
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2015
End Marketing Date
04-30-2023
Listing Expiration
04-30-2023
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0116-0113). Click a package code to view its specific billing and regulatory data.

0116-0113-04
118 mL in 1 BOTTLE, PLASTIC
0116-0113-08
237 mL in 1 BOTTLE, PLASTIC
0116-0113-32
946 mL in 1 BOTTLE, PLASTIC

* 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 0116-0113-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Cardinal Health Antiseptic Skin Cleanser, labeled by Xttrium Laboratories, Inc.. 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 Xttrium Laboratories, Inc. on May 01, 2015. The current certification is valid through April 30, 2023.

How is this Xttrium Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116011316. 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 (4-4-2)
0116-0113-16
11-Digit CMS (5-4-2)
00116-0113-16

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