Pdi Sani Hands Cloth
NDC Package 10819-3918-1

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

Package Information

Pdi Sani Hands (instant hand sanitizing wipes) cloths is pell back label slowly.Pull out wipe and reseal label.Unfold and use.Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. This formulation utilizes a cloth delivery system. Marketed by Professional Disposables International Inc, this product is identified by NDC 10819-3918 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
10819-3918-1
Package Description
20 APPLICATOR in 1 CELLO PACK / 4.15 mL in 1 APPLICATOR
Product Code
10819-3918
11-Digit Billing Format
10819391801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pdi Sani Hands
Non-Proprietary Name
Instant Hand Sanitizing Wipes
Substance Name
Alcohol
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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 .7 mL/mL
Usage Information
Pell back label slowly.Pull out wipe and reseal label.Unfold and use.Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry.If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.Discard after single use.

Regulatory & Marketing

Labeler Name
Professional Disposables International Inc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10819-3918-1 identifies a specific commercial package of 20 applicator in 1 cello pack / 4.15 ml in 1 applicator of Pdi Sani Hands, a human over the counter drug labeled by Professional Disposables International Inc. This cloth 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 Professional Disposables International Inc on April 01, 2016. The current certification is valid through December 31, 2026.

How is this Professional Disposables International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10819391801. 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 (5-4-1)
10819-3918-1
11-Digit CMS (5-4-2)
10819-3918-01

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