PURKLENZ- chloroxylenol liquid

PurKlenz by

Drug Labeling and Warnings

PurKlenz by is a Otc medication manufactured, distributed, or labeled by PurKlenz Formulations Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 FRAGRANCEContains 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 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 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

INGREDIENTS AND APPEARANCE

PURKLENZ 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49436-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.949 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
LANOLIN OIL (UNII: OVV5IIJ58F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49436-291-01	900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2012
2	NDC: 49436-291-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012
3	NDC: 49436-291-03	1000 in 1 BOX	05/01/2012
3		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 49436-291-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2012

Labeler - PurKlenz Formulations Inc. (078444179)

Registrant - PurKlenz Formulations Inc. (078444179)