Alcohol Prep Pads Large Sterile Cloth
NDC Package 83446-002-01

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

Alcohol Prep Pads Large Sterile (isopropyl alcohol cloth) cloths is use for preparation of skin prior to injection，apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection. This formulation utilizes a cloth delivery system. Marketed by Jinhua Jingdi Medical Supplies Co.,ltd, this product is identified by NDC 83446-002 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
83446-002-01
Package Description
100 BOX in 1 CARTON / 100 POUCH in 1 BOX / .8 mL in 1 POUCH
Product Code
83446-002
11-Digit Billing Format
83446000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alcohol Prep Pads Large Sterile
Non-Proprietary Name
Isopropyl Alcohol Cloth
Substance Name
Isopropyl 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.
  • 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
Use for preparation of skin prior to injection，apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Regulatory & Marketing

Labeler Name
Jinhua Jingdi Medical Supplies Co.,ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2023
Listing Expiration
12-31-2027
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 (83446-002). Click a package code to view its specific billing and regulatory data.

83446-002-02
100 BOX in 1 CARTON / 100 POUCH in 1 BOX / .8 mL 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 83446-002-01 identifies a specific commercial package of 100 box in 1 carton / 100 pouch in 1 box / .8 ml in 1 pouch of Alcohol Prep Pads Large Sterile, a human over the counter drug labeled by Jinhua Jingdi Medical Supplies Co.,ltd. This cloth is formulated for topical use and contains isopropyl 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 Jinhua Jingdi Medical Supplies Co.,ltd on March 01, 2023. The current certification is valid through December 31, 2027.

How is this Jinhua Jingdi Medical Supplies Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83446000201. 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)
83446-002-01
11-Digit CMS (5-4-2)
83446-0002-01

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