Signature Care Medicated Cooling Cloth
NDC Package 21130-928-00

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

Package Information

Signature Care Medicated Cooling (witch hazel) cloths is directionsAdults:when practical clean the affected area with mild soap and warm water, and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applyingapply externally to the affected area up to 6 times daily or after each bowel movementafter application, discard pad Children under 12 years of age: ask a doctor. This formulation utilizes a cloth delivery system. Marketed by Better Living Brands, Llc, this product is identified by NDC 21130-928 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
21130-928-00
Package Description
100 CLOTH in 1 JAR
Product Code
21130-928
11-Digit Billing Format
21130092800
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Signature Care Medicated Cooling
Non-Proprietary Name
Witch Hazel
Substance Name
Witch Hazel
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)
WITCH HAZEL 500 mg/1
Usage Information
DirectionsAdults:when practical clean the affected area with mild soap and warm water, and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applyingapply externally to the affected area up to 6 times daily or after each bowel movementafter application, discard pad Children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Better Living Brands, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-03-2016
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 21130-928-00 identifies a specific commercial package of 100 cloth in 1 jar of Signature Care Medicated Cooling, a human over the counter drug labeled by Better Living Brands, Llc. This cloth is formulated for topical use and contains witch hazel 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 Better Living Brands, Llc on October 03, 2016. The current certification is valid through December 31, 2026.

How is this Better Living Brands, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130092800. 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)
21130-928-00
11-Digit CMS (5-4-2)
21130-0928-00

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