PURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]

PURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]
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NDC 49436-291-01, 49436-291-02, 49436-291-03, 49436-291-05
Set ID 9f1223a8-a256-46f0-b01d-01b32ca09d48
Category HUMAN OTC DRUG LABEL
Packager PurKlenz Formulations Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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 AntisepticSkin 5 Label

  • 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 AntiTowelette 1 Label



  • 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 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

    PurKlenz 500mL 05

  • INGREDIENTS AND APPEARANCE
    PURKLENZ 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49436-291
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.949 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49436-291-01900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    2NDC:49436-291-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    3NDC:49436-291-031000 in 1 BOX05/01/2012
    33.5 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:49436-291-05500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2012
    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)

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