NDC 0327-0001 Clorpactin Wcs-90

Chlorine

NDC Product Code 0327-0001

NDC 0327-0001-10

Package Description: 5 VIAL in 1 BOX > 2 g in 1 VIAL

NDC Product Information

Clorpactin Wcs-90 with NDC 0327-0001 is a a human over the counter drug product labeled by United-guardian, Inc.. The generic name of Clorpactin Wcs-90 is chlorine. The product's dosage form is powder, for solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 672963 and 672965.

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clorpactin Wcs-90 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
  • SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
  • SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: United-guardian, Inc.
Labeler Code: 0327
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-1955 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Clorpactin Wcs-90 Product Label Images

Clorpactin Wcs-90 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Active Chlorine Derived from Calcium Hypochlorite 3-4%Available Chlorine 6-8%

Purpose

Topical Antisepsis

Uses

Topical Antisepsis

Warnings

Caution Never use Clorpactin WCS-90 powder as is. This product is intended to be used only as a solution (in water). The powder can cause damage to human tissue, and particularly to infected areas or mucous membrane tissue.

Directions

Add the Clorpactin WCS-90 powder to sterile or deionized water at room temperature (20-25° C.). The powder dissolves slowly in water. As a result even after 2-3 minutes of stirring or mixing some residue of incompletely dissolved product will remain. This residue consists of inactive ingredients and therefore there is no necessity to continue to stir or mix for a longer period of time. This residue can be removed by either filtering the solution through a coarse laboratory filter or allowing the solution to settle for about 5 minutes and then decanting the clear solution for use.StorageClorpactin WCS-90 solutions should preferably be used as soon as possible after preparation. If the solution must be stored, it can be kept refrigerated (4-8° C.) for up to 14 days in a capped or sealed plastic or glass container using a non-metallic cap. It can be stored at room temperature (20-25° C.) for up to 7 days after preparation. Handling As with any chlorinated product, Clorpactin WCS-90 solution should be prepared in a ventilated area and inhalation of the vapors should be minimized. The solution can cause bleaching of fabrics or other materials if splashing or spilling occurs.

Inactive Ingredients

Sodium acid pyrophosphate, sodium hexametaphosphate, sodium dodecylbenzene sulfonatePW018 - Revised September 30, 2010

* Please review the disclaimer below.