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PurKlenz

Dosage form: liquid
Ingredients: CHLOROXYLENOL 3mL in 100mL
Labeler: PurKlenz Formulations Inc.
NDC Code: 49436-291

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Uses:

  • For handwashing to decrease bacteria on the skin

Warnings

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.

Directions

Directions:

  • Apply as needed.
  • Scrub thoroughly for 30 seconds
  • Wipe excess with sterile gauze
  • Repeat

Other Information

Other Information:

  • Reseal container after use
  • Avoid freezing
  • Store between 4 degrees - 30 degrees C (40-86 degrees F)

Inactive Ingredients

Inactive Ingredients: Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, Cocamide DEA, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil, Yellow 10 (CI 47005)

Package Label

PurKlenz

Antiseptic Skin Cleanser

Chloroxylenol 3.0 %

For handwashing to decrease bacteria on the skin

DO NOT DILUTE

NDC 49436-291-01   30 Fl. Oz. (900 mL)

Made in Canada    Distributed in U.S.A. by PurKlenz Formulations Inc.   Questions or Comments?  www.purklenz.com    LOT/EXP









PURKLENZ 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49436-291
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
PROPYLENE GLYCOL 
COCAMIDOPROPYL BETAINE 
COCO DIETHANOLAMIDE 
HYPROMELLOSES 
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
LANOLIN OIL 
D&C YELLOW NO. 10 
Packaging
#Item CodePackage Description
1NDC:49436-291-01900 mL in 1 BOTTLE, PLASTIC
2NDC:49436-291-023780 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2012
Labeler - PurKlenz Formulations Inc. (078444179)
Registrant - PurKlenz Formulations Inc. (078444179)

Revised: 06/2012
Document Id: f3c23a65-a8ad-45f9-a66e-72718d546af7
Set id: 9f1223a8-a256-46f0-b01d-01b32ca09d48
Version: 3
Effective Time: 20120608
 
PurKlenz Formulations Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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