Label: PCMX WITH EMOLLIENT- chloroxylenol solution

  • 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 February 20, 2018

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  • ACTIVE INGREDIENT

    3.3% w/w Chloroxylenol

  • INDICATIONS & USAGE

    Uses

    For cleansing hands and forearms prior to surgery or patient care

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only

    Do not use in the eyes

    Stop use and ask a doctor if

    • skin shows symptoms of irritation, sensitivity, redness, pain or swelling
    • discontinue use if irritation and redness develop. If condition persists more than 72 hours consult a doctor.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean under nails with nail pick. Nails should be maintained with a 1 mm free edge
    • Wet hands and forearms
    • Apply 5 ml or palmful to hands and forearms
    • Scrub thoroughly for 3 minutes with a wet brush
    • Pay particular attention to the nails, cuticles and interdigital spaces
    • Rinse thoroughly with running water
    • Repeat
  • Other information

    • Store at room temperature
    • Avoid excessive heat above 40 deg C (104 deg F)
    • Protect from freezing
    • Latex Free
  • INACTIVE INGREDIENT

    Citric Acid, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium C12-15 Pareth-15 Sulfonate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Laryl Sulfate, Soy Acid, Styrene/VP Copolymer

  • QUESTIONS

    Questions?

    Call: 1-800-523-0502 (Mon. - Fri. 8 AM-5 PM CST)

  • PRINCIPAL DISPLAY PANEL

    Scrub Care 3.3% Chloroxylenol

    Emmollient CLeansing Solution

    Label

  • INGREDIENTS AND APPEARANCE
    PCMX WITH EMOLLIENT 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-9957
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C12-15 PARETH-15 SULFONATE (UNII: 353VA59XH8)  
    SOY ACID (UNII: HBA528N3PW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-9957-3946 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
    2NDC:52380-9957-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
    3NDC:52380-9957-9208198 mL in 1 DRUM; Type 0: Not a Combination Product02/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2004
    Labeler - Aplicare Products, LLC. (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC.081068252manufacture(52380-9957)
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