Purklenz Liquid
FDA Label NDC 49436-291

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purklenz Formulations Inc. for the product Purklenz (NDC 49436-291). 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, keep out of reach of children, uses, directions, other information, warnings, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Drug Facts

Active Ingredient:

  • Chloroxylenol 3.0%

Purpose

Purpose:

  • Antiseptic

Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion seek medical help or contact a Poison Control Center right away.

Uses


  • To decrease bacteria on the skin

Directions

  • For best results do not dilute
  • Apply as needed
  • Scrub thoroughly for 30 seconds
  • Wipe excess with sterile gauze
  • Repeat - liquid only
  • Massage package and remove towelette - towelette only
  • Fold gauze and repeat - towelette only



Other Information

Other Information:

  • Reseal container after use - liquid only
  • Avoid freezing
  • Store between 4° - 30° C (40-86° F)
  • Dispose after use - towelette only

Warnings

For external use only
Do not use if you are allergic or sensitive to any of the ingredients listed
When using this product avoid contact in or near eyes and mouth (oral mucosa).
In case of eye contact, flush eyes with water.
Stop and ask a doctor if irritation, rash or other allergic reaction develops.
In case of accidental ingestion seek medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil

Purklenz Antiseptic Skin Cleaner Label - 30 Fl Oz

PurKlenz®
Antiseptic Skin Cleanser

Chloroxylenol 3.0 % NO PARABEN • ALCOHOL • DYE • FRAGRANCE•
Contains No Paraben, Fragrance or Dye
30 FL. OZ. (900 mL)
NDC 49436-291-01  
Made in Canada   
Distributed in U.S.A. by
PurKlenz Formulations Inc.  
Questions or Comments? 
www.purklenz.com   



PURKlenz

PurKlenz Formulations Inc.

Purklenz Antiseptic Skin Cleanser - Towelette Label

PurKlenz®
Antiseptic Skin Cleanser

Contains No Paraben, Fragrance and Dye
1 Pre-moistened Single Use Towelette 4" X 6"

Net Content 3.5 mL
NDC 494-291-03

Purklenz Antitowellette Label (Purklenz Antitowellette)

Purklenz Antitowellette Label (Purklenz Antitowellette)


Purklenz Antitowelette 1 Label (Purklenz Antitowelette1)

Purklenz Antitowelette 1 Label (Purklenz Antitowelette1)




Purklenz Antiseptic Skin Cleaner - Drum Label

PurKlenz® Antiseptic Skin Cleanser
Gross weight 111 kg (278 lbs)
Net weight 105 kg (263 lbs)
Volume 105 Liters (28 Gallons)
NDC 494-291-99Lot 4D1      MADE IN CANADA
Expiry April 2016
PurKlenze Formulations Inc.

Purklenz Drum Label (Purklenz Drum)

Purklenz Drum Label (Purklenz Drum)

Purklenz Antiseptic Skin Cleaner Label - 16 Fl Oz

PurKlenz®
Antiseptic Skin Cleanser

NO - Paraben – Alcohol – Dye - Fragrance

500mL
(16 FL. OZ.)
NDC: 49436-291-05

Product Facts
Active ingredienPurpose:
Chloroxylenol 3%.............................Antiseptic

Uses: To decrease bacteria on the skin.

Warnings: For external use only. Do not ingest.
Do not use if you are allergic or sensitive to any of the ingredients listed.

When using this product avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water.

Stop use & ask a doctor if irritation, rash or other allergic reaction develops.

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.

Directions:

  • For best results do not dilute
  • Apply as needed
  • Scrub thoroughly for at least 30 seconds
  • Rinse
  • Repeat
  • Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

    Inactive ingredients: Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil

    Made in Canada
    Distributed in U.S.A. by PurKlenz Formulations Inc.

    Questions or Comments? www.purklenz.com

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