Clorpactin Wcs-90 Powder, For Solution
FDA Label NDC 0327-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United-guardian, Inc. for the product Clorpactin Wcs-90 (NDC 0327-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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.

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 (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 sulfonate

PW018 - Revised September 30, 2010

Package/Label Principal Display Panel

NDC - 0327 -0001 - 10

The Ultimate Topical Bioticide

Clorpactin® wcs-90

Brand of Oxychlorosene, Sodium

  • Keep Under Refrigeration
  • Bactericide
  • Virucide
  • Fungicide
  • Sporicide

    • Active ingredient:
    Active chlorine derived from
    Calcium hypochlorite 3-4%
    Available chlorine 6-8%

    Contents: 5 - 2 gram bottles

    Guardian Laboratories div. of United-Guardian, Inc. Hauppauge, NY 11788

    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 (6b3b2d67 4142 4a98 9a73 Fb107b19a636 01)

    Box Label (6b3b2d67 4142 4a98 9a73 Fb107b19a636 01)

    Box Label

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