Label: REFRESH PUREBAC FOAM- chloroxylenol liquid

  • NDC Code(s): 11084-160-12, 11084-160-20, 11084-160-27
  • Packager: SC Johnson Professional USA, Inc.
  • 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 March 16, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Chloroxylenol, 0.5%

  • Purpose

    Antibacterial

  • Uses

    • For handwashing to reduce bacteria on the skin
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply foaming cleanser to dry hands
    • Rub hands together to spread lather
    • Wash for 15-20 seconds
    • Rinse & dry hands thoroughly
  • Inactive ingredients

    Aqua (Water), Propylene Glycol, TEA-lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Tetrasodium EDTA, Citric Acid, Magnesium Nitrate, Magnesium Chloride, Diazolidinyl Urea, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    SCJ PROFESSIONAL
    A family company™

    NDC 11084-160-27

    Refresh PureBac™ FOAM

    ANTIMICROBIAL FOAM SOAP
    Dye & Fragrance-Free Antibacterial Foam Handwash

    Stock #:PBF1L/4000000752

    1 L (33.8 fl oz)

    SC Johnson Professional USA, Inc.
    Charlotte, NC 28217
    1-800-248-7190. www.scjp.com

    deb
    SKIN CARE

    Pat.www.scjp.com/patents

    1000002970/1020

    PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    REFRESH PUREBAC FOAM 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    PPG-24-GLYCERETH-24 (UNII: V341SPY84U)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-160-271 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/15/2015
    2NDC:11084-160-121.2 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/15/2015
    3NDC:11084-160-202 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2015
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    SC Johnson Professional USA, Inc.078805627manufacture(11084-160)