Label: PINK ANTIBACTERIAL- chloroxylenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 9, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroxylenol 0.3%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings:

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply to hands, add small amount of water and lather.

    Work until soil is emulsified.

    Rinse and wipe dry.

  • STORAGE AND HANDLING

    Other Information:

    Store at 20 to 25 C. (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, TEA-Dodecylbenzosulphonate, Cocamide DEA, Acrylate Ester Copolymer, Propylene Glycol, Borax, Acrylates/PEG-10 Maleate/Styrene Copolymer, EDTA, Fragrance and DC Red 33.

  • PRINCIPAL DISPLAY PANEL

    PK

    Pink Antibacterial

    is a rich lathering lotion soap that is gentle

    enough for everyday use. Contains an

    antiseptic ingredient that helps protect the

    skin from minor infections and irritation. It is

    ideal for institutional use. Biodegradable.

    Woodbine Products Company

    915 West Smith Road

    Medinia, OH 44256

    www.woodbineproducts.com

    Pink

    Antibacterial

    Lotion Soap

    Stock#125      2500 ml (84 fl. oz.)

    Made in the USA

    container label

  • INGREDIENTS AND APPEARANCE
    PINK ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1009-1118 mL in 1 BOTTLE, PLASTIC
    2NDC:11429-1009-2800 mL in 1 BOTTLE, PLASTIC
    3NDC:11429-1009-42125 mL in 1 BOTTLE, PLASTIC
    4NDC:11429-1009-52500 mL in 1 BOTTLE, PLASTIC
    5NDC:11429-1009-63785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1009)