Prepiel K365 Clean Gel
NDC Package 90028-070-01

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.

Prepiel K365 Clean Gel is ■ Place enough product on hands to cover all surfaces. Marketed by Jmb Cosline Co.,ltd, this product is identified by NDC 90028-070 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
90028-070-01
Package Description
500 mL in 1 BOTTLE, PUMP
Product Code
90028-070
11-Digit Billing Format
90028007001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prepiel K365 Clean Gel
Dosage Form
-
Usage Information
■ Place enough product on hands to cover all surfaces. Rub hands together until dry. ■ Supervise children under 6 years of age when using this product to avoid swallowing. ■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.) ■ This product is intended only for hand sanitizing. ■ To prevent contents from drying out and contaminants from entering, close lid completely after use. ■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish. ■ Do not use over bandages, castings, etc. as irritation may occur.

Regulatory & Marketing

Labeler Name
Jmb Cosline Co.,ltd
FDA Application #
part333A
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
02-09-2021
Listing Expiration
12-31-2022
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 90028-070-01 identifies a specific commercial package of 500 ml in 1 bottle, pump of Prepiel K365 Clean Gel, labeled by Jmb Cosline Co.,ltd. 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 Jmb Cosline Co.,ltd on February 09, 2021. The current certification is valid through December 31, 2022.

How is this Jmb Cosline Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 90028007001. 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)
90028-070-01
11-Digit CMS (5-4-2)
90028-0070-01

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