Procedure Enhancement System
NDC Package 70604-040-00

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.

Procedure Enhancement System is apply liberally 15 minutes before sun exposureReapply:After 40 minutes of swimming or sweatingImmediately after towel dryingAt least every two hoursChildren under 6 months of age:Ask a doctor.Sun Protection measures. Marketed by Alastin Skincare, Inc., this product is identified by NDC 70604-040 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
70604-040-00
Package Description
1 KIT in 1 BAG * 29.6 mL in 1 BOTTLE, PUMP * 29.6 mL in 1 TUBE * 53.8 g in 1 TUBE (70604-030-02) * 53.2 mL in 1 BOTTLE, PUMP
Product Code
70604-040
11-Digit Billing Format
70604004000

Clinical Specifications

Proprietary Name
Procedure Enhancement System
Dosage Form
-
Usage Information
Apply liberally 15 minutes before sun exposureReapply:After 40 minutes of swimming or sweatingImmediately after towel dryingAt least every two hoursChildren under 6 months of age:Ask a doctor.Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10am - 2pmWear long-sleeved shirts, pants, hats and sunglasses

Regulatory & Marketing

Labeler Name
Alastin Skincare, Inc.
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-17-2021
Listing Expiration
12-31-2025
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 70604-040-00 identifies a specific commercial package of 1 kit in 1 bag * 29.6 ml in 1 bottle, pump * 29.6 ml in 1 tube * 53.8 g in 1 tube (70604-030-02) * 53.2 ml in 1 bottle, pump of Procedure Enhancement System, labeled by Alastin Skincare, 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 Alastin Skincare, Inc. on September 17, 2021. The current certification is valid through December 31, 2025.

How is this Alastin Skincare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70604004000. 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)
70604-040-00
11-Digit CMS (5-4-2)
70604-0040-00

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