Antiseptic Hand Sanitizer Gel
NDC Package 76138-113-07

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

Antiseptic Hand Sanitizer (ethyl alcohol) gel is • Spread on both hands. This formulation utilizes a gel delivery system. Marketed by Innovation Specialties Inc, this product is identified by NDC 76138-113 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
76138-113-07
Package Description
53 mL in 1 BOTTLE
Product Code
76138-113
11-Digit Billing Format
76138011307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Antiseptic Hand Sanitizer
Non-Proprietary Name
Ethyl Alcohol
Substance Name
Alcohol
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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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)
Usage Information
• Spread on both hands.

Regulatory & Marketing

Labeler Name
Innovation Specialties Inc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-02-2016
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 (76138-113). Click a package code to view its specific billing and regulatory data.

76138-113-01
59 mL in 1 BOTTLE
76138-113-02
15 mL in 1 BOTTLE
76138-113-03
30 mL in 1 BOTTLE
76138-113-16
1 BOTTLE in 1 BAG / 15 mL in 1 BOTTLE

* 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 76138-113-07 identifies a specific commercial package of 53 ml in 1 bottle of Antiseptic Hand Sanitizer, a human over the counter drug labeled by Innovation Specialties Inc. This gel 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 Innovation Specialties Inc on January 02, 2016. The current certification is valid through December 31, 2026.

How is this Innovation Specialties Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76138011307. 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)
76138-113-07
11-Digit CMS (5-4-2)
76138-0113-07

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