Skin Pharmacy Advanced Acne Therapy Kit
NDC Package 68634-067-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Skin Pharmacy Advanced Acne Therapy Kit (salicylic acid, benzoyl peroxide) kits is use morning and night. This formulation utilizes a kit delivery system. Marketed by Amcol Health & Beauty Solutions, Inc. Dba, this product is identified by NDC 68634-067 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
68634-067-01
Package Description
1 KIT in 1 CARTON * 22 mL in 1 TUBE * 12 mL in 1 TUBE * 118 mL in 1 TUBE
Product Code
68634-067
11-Digit Billing Format
68634006701

Clinical Specifications

Proprietary Name
Skin Pharmacy Advanced Acne Therapy Kit
Non-Proprietary Name
Salicylic Acid, Benzoyl Peroxide
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
Use morning and night. Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside use sunscreen.

Regulatory & Marketing

Labeler Name
Amcol Health & Beauty Solutions, Inc. Dba
Product Type
Human Otc Drug
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-01-2014
Listing Expiration
12-31-2026
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 68634-067-01 identifies a specific commercial package of 1 kit in 1 carton * 22 ml in 1 tube * 12 ml in 1 tube * 118 ml in 1 tube of Skin Pharmacy Advanced Acne Therapy Kit, a human over the counter drug labeled by Amcol Health & Beauty Solutions, Inc. Dba. This kit is formulated for topical use and contains 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 Amcol Health & Beauty Solutions, Inc. Dba on October 01, 2014. The current certification is valid through December 31, 2026.

How is this Amcol Health & Beauty Solutions, Inc. Dba product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68634006701. 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)
68634-067-01
11-Digit CMS (5-4-2)
68634-0067-01

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