Label: ANTIMICROBIAL FOAMING HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 69674-210-01, 69674-210-04
  • Packager: Saraya Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.12%

  • PURPOSE

    Purpose

    Antiseptic Hand Cleanser

  • INDICATIONS & USAGE

    Uses​

    • Hand wash to help reduce bacteria that potentially can cause diseases
    • Helps to prevent cross-contamination
    • Helps to prevent drying of the skin
    • Recommended for repeated use
  • WARNINGS

    Warnings

    • For external use only
  • WHEN USING

    When using this product

    • Do not use in or near the eyes
  • 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 and forearms
    • Apply appropriate amount to hands, wrists, and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse with water
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    Benzyl alcohol, cocoamidopropyl betaine, dehydroacetic acid, glycerine, phenoxyethanol, polyethylene-propylene glycol, tetra-sodium EDTA, water

  • QUESTIONS

    Questions?

    Call Saraya Healthcare USAMon - Fri

    9am - 4pm PST at 888.822.1801

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Saraya Healthcare USA

    P.O. Box 1360

    Penn Valley, CA 95946

    866.822.1801

    sarayahealthcareusa.com

  • SARAYAHealthcare USA

    – 0.12% Benzalkonium Chloride (BZK) formula

    – pH balanced

    – Formulated with emollients to help keep skin soft

    Antimicrobial Foaming Hand Soap

    Net Contents: 1250mL (42 fl oz)

    Saraya BZK Soap

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69674-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69674-210-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    2NDC:69674-210-041250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/14/2016
    Labeler - Saraya Healthcare (079729980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69674-210)
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