Clorpactin Wcs-90

Chlorine


United-guardian, Inc.
Human Otc Drug
NDC 0327-0001
Clorpactin Wcs-90 also known as Chlorine is a human otc drug labeled by 'United-guardian, Inc.'. National Drug Code (NDC) number for Clorpactin Wcs-90 is 0327-0001. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Clorpactin Wcs-90 drug includes Chlorine - .16 g/2g . The currest status of Clorpactin Wcs-90 drug is Active.

Drug Information:

Drug NDC: 0327-0001
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Clorpactin Wcs-90
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Chlorine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: United-guardian, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Powder, For Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CHLORINE - .16 g/2g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 01 Jan, 1955
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:United-Guardian, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:672963
672965
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:4R7X1O2820
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0327-0001-105 VIAL in 1 BOX (0327-0001-10) / 2 g in 1 VIAL01 Jan, 1955N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose topical antisepsis

Product Elements:

Clorpactin wcs-90 chlorine chlorine chlorine sodium acid pyrophosphate sodium polymetaphosphate sodium dodecylbenzenesulfonate

Indications and Usage:

Uses topical antisepsis

Warnings:

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.

Dosage and Administration:

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. storage clorpactin wcs-90 solutions should preferably be used as soon as possible after preparation. if the solution must be stored, it can be kept refrigerated (2-8° c.) for up to 10 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 3 days after preparation. handling as with any chlorinated product, cl
orpactin 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.

Package Label Principal Display Panel:

Package/label principal display panel ndc - 0327 -0001 - 10 the ultimate topical bioticide clorpactin® wcs-90 brand of oxychlorosene, sodium* • refrigerate upon arrivial bactericide • virucide fungicide • sporicide contents: 5 - 2 gram bottles active ingredient: active chlorine derived from calcium hypochlorite 3-4% available chlorine 6-8% guardian laboratories div. of united-guardian, inc. hauppauge, ny 11788 caution: keep out of reach of children clorpactin® wcs-90 for topical antisepsis directions: pour the contents of one bottle into a quart of cool or lukewarm water, in a glass or plastic container. stir or shake for several minutes. use the freshly prepared solution for irrigating the infected area as a rinse, soak or spray. repeat applications with a fresh portion of the solution, or allow to soak for 20 to 30 minutes until symptoms disappear or are relieved. see enclosed insert for further information made in u.s.a. box label image-01


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.