Face Acne Wash Gel
NDC Package 84365-008-01

11-digit billing NDC: 84365000801
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Face Acne Wash (benzoyl peroxide) gel is wet area to be cleaned • apply acne wash and gently massage into damp skin • Wait 1-3 minutes • Rinse thoroughly • Because excessive drying may occur, start with one application daily, then gradually increase to two to three times daily as needed or directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day. This formulation utilizes a gel delivery system. Marketed by Shield Skin Llc, this product is identified by NDC 84365-008 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
84365-008-01
Package Description
150 mL in 1 TUBE
Product Code
84365-008
11-Digit Billing Format
84365000801

Clinical Specifications

Proprietary Name
Face Acne Wash
Non-Proprietary Name
Benzoyl Peroxide
Substance Name
Benzoyl Peroxide
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
BENZOYL PEROXIDE 4 g/100mL
Usage Information
Wet area to be cleaned • apply acne wash and gently massage into damp skin • Wait 1-3 minutes • Rinse thoroughly • Because excessive drying may occur, start with one application daily, then gradually increase to two to three times daily as needed or directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Regulatory & Marketing

Labeler Name
Shield Skin Llc
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-25-2026
Listing Expiration
12-31-2027
Exclude Flag
N
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 84365-008-01 identifies a specific commercial package of 150 ml in 1 tube of Face Acne Wash, a human over the counter drug labeled by Shield Skin Llc. This gel is formulated for topical use and contains benzoyl peroxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Shield Skin Llc on October 25, 2026. The current certification is valid through December 31, 2027.

How is this Shield Skin Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84365000801. 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)
84365-008-01
11-Digit CMS (5-4-2)
84365-0008-01

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