Label: HIGHMARK PROFESSIONAL PINK ANTIMICROBIAL LTN SP- 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 November 22, 2013

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

  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antimicrobial

  • Use

    Handwash to help decrease bacteria on the skin

    Recommended for repeated use

  • Directions

    Wet hands

    Apply a small amount of product and work into a lather

    Rinse well and dry hands completely

  • Inactive ingredients

    Water (Aqua), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Hydrolyzed Vegetable Protein, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum), Red 33 (CI 17200), Red 40 (CI 16035)

  • Warnings

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • PRINCIPAL DISPLAY PANEL

    For general hand washing and germ killing.


    Alert Open refillable reservoir dispensers are susceptible to microbial contamination even when using antimicrobial soaps. Ideally, liquid products should be dispensed from closed, SANITARY SEALEDTM  refills. Open refillable reservoir dispensers should be washed and sanitized before every refilling. Soaps should not be added to a partially empty dispenser as this practice of "topping off" may lead to bacterial contamination of soaps and compromise the beneficial effects of hand cleaning.

    Label

  • INGREDIENTS AND APPEARANCE
    HIGHMARK PROFESSIONAL PINK ANTIMICROBIAL LTN SP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61139-422
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCONUT ACID (UNII: 40U37V505D)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61139-422-373785 mL in 1 JUG
    2NDC:61139-422-101000 mL in 1 BOTTLE
    3NDC:61139-422-202000 mL in 1 BOTTLE
    4NDC:61139-422-891200 mL in 1 BOTTLE
    5NDC:61139-422-901250 mL in 1 BOTTLE
    6NDC:61139-422-80800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/22/2013
    Labeler - Office Max, Inc. (009073099)