Aqua Plus Acne Treatment System
NDC Package 71471-269-27

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.

Aqua Plus Acne Treatment System is wet your skin and massage the Aqua+ Daily Cleanser over your entire face, avoiding your eyes. Marketed by Totally Clear Products, Inc, this product is identified by NDC 71471-269 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
71471-269-27
Package Description
1 KIT in 1 BOX * 30 mL in 1 BOTTLE (71471-312-27) * 50 mL in 1 BOTTLE (71471-416-27) * 50 mL in 1 BOTTLE (71471-561-27)
Product Code
71471-269
11-Digit Billing Format
71471026927
RxNorm Crosswalk
  • RxCUI: 1047362 - salicylic acid 1 % Topical Solution
  • RxCUI: 1047362 - salicylic acid 10 MG/ML Topical Solution
  • RxCUI: 1943754 - {1 (30 ML) (salicylic acid 0.015 MG/MG Topical Gel) / 1 (50 ML) (salicylic acid 10 MG/ML Topical Solution) / 1 (50 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } Pack
  • RxCUI: 1943754 - salicylic acid 1 % Topical Solution (50 mL) / salicylic acid 1.5 % Topical Gel (30 mL) / salicylic acid 2 % Medicated Liquid Soap (50 mL) Pack
  • RxCUI: 1943754 - salicylic acid 1 % Topical Solution (50 ML) / salicylic acid 1.5 % Topical Gel (30 ML) / salicylic acid 2 % Medicated Liquid Soap (50 ML) Pack

Clinical Specifications

Proprietary Name
Aqua Plus Acne Treatment System
Dosage Form
-
Usage Information
Wet your skin and massage the Aqua+ Daily Cleanser over your entire face, avoiding your eyes. Use the Aqua+ Daily Cleanser only once a day until your skin acclimates, after which you can move to twice-per-day applications. Rinse with water and gently pat your skin with a clean towel. Clean the skin thoroughly before applying the Aqua+ Spotter Gel. Cover the entire affected area with a thin layer, one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed, or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Regulatory & Marketing

Labeler Name
Totally Clear Products, Inc
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-01-2017
Listing Expiration
12-31-2018
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 71471-269-27 identifies a specific commercial package of 1 kit in 1 box * 30 ml in 1 bottle (71471-312-27) * 50 ml in 1 bottle (71471-416-27) * 50 ml in 1 bottle (71471-561-27) of Aqua Plus Acne Treatment System, labeled by Totally Clear Products, 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 Totally Clear Products, Inc on September 01, 2017. The current certification is valid through December 31, 2018.

How is this Totally Clear Products, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71471026927. 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)
71471-269-27
11-Digit CMS (5-4-2)
71471-0269-27

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