Label: PC511 ANTIMICROBIAL- chloroxylenol soap

  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Chloroxylenol 0.3% w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

    • removes dirt and grease quickly, leaving the skin feeling clean and fresh
  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
  • Directions

     apply small amount of product to hands.  hold hands under water and work cleaner into lather.   rinse hands with water and wipe clean.

  • Other information

     store at room temperature

     recommended for use in Wall Mount Dispenser

  • Inactive ingredients:

    Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Glycol distearate, Myristyl alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #4.

  • PRINCIPAL DISPLAY PANEL - 800 mL Bag Label CLEAN N FRESH® Lotion Hand Soap Plus (Antimicrobial) 800 ml Manufactured by: CARROLL® Company Garland, TX 75041

    image description

  • INGREDIENTS AND APPEARANCE
    PC511 ANTIMICROBIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10685-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10685-511-17800 mL in 1 BAG; Type 0: Not a Combination Product10/16/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/16/2013
    Labeler - CARROLL COMPANY (007372329)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!