Sanitex Antibacterial Hand Wipes
NDC Package 53118-001-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sanitex Antibacterial Hand Wipes is for  40 Count wipes:Take wipe and rub thoroughly over all surfaces of both hands.Rub hands together briskly to dry and allow to air dry.Dispose of wipe in trash.Do not flush.For 20 Count wipes:                         Adults and Children 2 Years and Over: Apply to hands and face. Marketed by Premier Care Industries, Inc, this product is identified by NDC 53118-001 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
53118-001-01
Package Description
40 PACKAGE in 1 CANISTER / 3 g in 1 PACKAGE
Product Code
53118-001
11-Digit Billing Format
53118000101

Clinical Specifications

Proprietary Name
Sanitex Antibacterial Hand Wipes Citrus Scent
Dosage Form
-
Usage Information
For  40 Count wipes:Take wipe and rub thoroughly over all surfaces of both hands.Rub hands together briskly to dry and allow to air dry.Dispose of wipe in trash.Do not flush.For 20 Count wipes:                         Adults and Children 2 Years and Over: Apply to hands and face. Allow to dry without wiping.                Children Under 2 Years: Ask a doctor before use.To Dispense:Peel back front label slowly. Remove Wipes.To Reseal: Firmly run thumb over the label. Dispose of wipe in trash. Do not flush.

Regulatory & Marketing

Labeler Name
Premier Care Industries, Inc
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
06-18-2015
Listing Expiration
12-31-2019
Exclude Flag
I
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 (53118-001). Click a package code to view its specific billing and regulatory data.

53118-001-02
20 POUCH in 1 BAG / 3 g in 1 POUCH

* 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 53118-001-01 identifies a specific commercial package of 40 package in 1 canister / 3 g in 1 package of Sanitex Antibacterial Hand Wipes Citrus Scent, labeled by Premier Care Industries, Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Premier Care Industries, Inc on June 18, 2015. The current certification is valid through December 31, 2019.

How is this Premier Care Industries, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53118000101. 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)
53118-001-01
11-Digit CMS (5-4-2)
53118-0001-01

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