Label: CARROLLCLEAN (chloroxylenol- pcmx soap

  • 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 November 6, 2020

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

  • Active ingredient

    Chloroxylenol 0.25% w/v

  • Purpose

    Antimicrobial

  • Uses

    • hand washing in public washrooms, work areas, healthcare facilities, office buildings, food service facilities, and whatever cleanliness and antimicrobial properties are desired.
  • Warnings

    For external use only

  • When using this product

    • do not use in or near eyes
  • Keep out of reach of children

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

  • Directions

    • apply small amount of product to hands
    • hold hands under water and work cleaner into lather
    • rinse with water and wipe clean
  • Other information

    • store at room temperature
  • Inactive ingredients section

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Dimethylol-5,5-dimethylhydantoin, Linear Ethoxylated Alcohol, Propylene Glycol, Polyethylene Glycol Distereate, Fragance, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methyllisothiazolinone, Isopropyl Myristate, Citric acid, FD & C Red #40, D & C Red #33

  • Package label

    Clean n Fresh

  • INGREDIENTS AND APPEARANCE
    CARROLLCLEAN 
    chloroxylenol (pcmx) soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73708-524
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.282 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) 7.85 mL  in 100 mL
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.099 mL  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 4.132 mL  in 100 mL
    C9-11 PARETH-8 (UNII: 80E6PSE1XL) 0.242 mL  in 100 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005 mL  in 100 mL
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 0.317 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 84.307 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.026 mL  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 2.146 mL  in 100 mL
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0004 mL  in 100 mL
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) 0.038 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.221 mL  in 100 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0002 mL  in 100 mL
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.334 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73708-524-17800 mL in 1 BAG; Type 0: Not a Combination Product11/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/06/2020
    Labeler - CarrollCLEAN LCC (081222623)
    Registrant - CarrollCLEAN LCC (081222623)
    Establishment
    NameAddressID/FEIBusiness Operations
    CarrollCLEAN081222623manufacture(73708-524)