Label: HEALTHCARE PERSONNEL HANDWASH- ethanol, benzalkonium chloride 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 January 2, 2019

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Ethanol 65.9%

    Benzalkonium Chloride 0.10%

  • PURPOSE

    Purpose

    Antiseptic

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Sterilizes hands to help reduce bacteria that accidentally can cause diseases
    • Helps to prevent cross-contamination
    • Helps prevent drying of the skin
    • Recommended for repeated use
  • WARNINGS

    Warnings

    • For external use only
    • Flammable, keep away from fire or flame
  • WHEN USING

    When using this product

    • Do not use in or near eyes
    • Use in a well-ventilated area
    • Discontinue use if irritation and redness develop
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with spray, covering entire surface of hands, especially the fingernails and cuticles
    • Rub hands together until dry
  • STORAGE AND HANDLING

    Other information

    • Store in a cool, dry place below 104°F
  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, water

  • QUESTIONS

    Questions?

    Contact Saraya Healthcare USA Mon - Fri 9am-4pm PST at 866.822.1801

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Saraya Healthcare USA

    P.O. Box 1360

    Penn Valley, CA 95946

    866.822.1801

    sarayahealthcareusa.com

  • SARAYA Healthcare USA

    Healthcare Personnel Handwash

    – Ethanol/BZK formula

    – Atomized mist saturates cuticles and crevices of hands and fingers

    – Formulated with emollients to help keep hands soft

    Net Contents: 1000mL (34 fl oz)

    Saraya Hand Sanitizer Spray Alc BZK

  • INGREDIENTS AND APPEARANCE
    HEALTHCARE PERSONNEL HANDWASH 
    ethanol, benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69674-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.9 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69674-110-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    2NDC:69674-110-0745 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    3NDC:69674-110-041000 mL in 1 BAG; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2016
    Labeler - Saraya Healthcare (079729980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69674-110)
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