Gel Antiseptic Handwash Liquid
NDC Package 81628-693-01

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

Package Information

Gel Antiseptic Handwash liquids is place a palmful ( 5 grams) of product in one hand,.Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).Will air dry in 15 seconds. This formulation utilizes a liquid delivery system. Marketed by Shop Bee's Wax Llc, this product is identified by NDC 81628-693 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
81628-693-01
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
81628-693
11-Digit Billing Format
81628069301

Clinical Specifications

Proprietary Name
Gel Antiseptic Handwash
Non-Proprietary Name
Gel Antiseptic Handwash
Substance Name
Alcohol
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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)
ALCOHOL 67 mL/100mL
Usage Information
Place a palmful ( 5 grams) of product in one hand,.Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).Will air dry in 15 seconds.

Regulatory & Marketing

Labeler Name
Shop Bee's Wax Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-16-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81628-693). Click a package code to view its specific billing and regulatory data.

81628-693-02
236 mL in 1 BOTTLE, PLASTIC
81628-693-03
3785 mL in 1 BOTTLE, PLASTIC

* 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 81628-693-01 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Gel Antiseptic Handwash, a human over the counter drug labeled by Shop Bee's Wax Llc. This liquid is formulated for topical use and contains alcohol 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 Shop Bee's Wax Llc on November 16, 2012. The current certification is valid through December 31, 2026.

How is this Shop Bee's Wax Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81628069301. 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)
81628-693-01
11-Digit CMS (5-4-2)
81628-0693-01

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