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
  • 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 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 USA Mon - 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

  • SARAYA Healthcare 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 not finalpart333E04/14/2016
    Labeler - Saraya Healthcare (079729980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69674-210)
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