Cleanwell Natural Original Hand Sanitizer Wipes
NDC Package 28107-002-08

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 inactivated by the FDA.

Cleanwell Natural Original Hand Sanitizer Wipes is apply thoroughly to hands and face as desired. Marketed by Cleanwell, Llc, this product is identified by NDC 28107-002 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
28107-002-08
Package Description
.04328 kg in 1 POUCH
Product Code
28107-002
11-Digit Billing Format
28107000208

Clinical Specifications

Proprietary Name
Cleanwell Natural Original Hand Sanitizer Wipes
Dosage Form
-
Usage Information
Apply thoroughly to hands and face as desired. Close lid between uses to retain moisture.  Do not flush wipes.  To Dispense:  Lift tab at front of lid to open.  Pull up corner of center sheet and thread through dispenser slit in lid.  Pull out exposed wipe at 45 angle and snap off.  The next wipe is ready for dispensing.

Regulatory & Marketing

Labeler Name
Cleanwell, Llc
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
06-15-2010
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (28107-002). Click a package code to view its specific billing and regulatory data.

28107-002-09
.16952 kg in 1 CANISTER

* 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 28107-002-08 identifies a specific commercial package of .04328 kg in 1 pouch of Cleanwell Natural Original Hand Sanitizer Wipes, labeled by Cleanwell, 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 Cleanwell, Llc on June 15, 2010. The current certification is valid through December 31, 2019.

How is this Cleanwell, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 28107000208. 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)
28107-002-08
11-Digit CMS (5-4-2)
28107-0002-08

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