Label: SAFEHANDS- benzalkonium chloride liquid

  • NDC Code(s): 60867-102-02, 60867-102-07, 60867-102-18
  • Packager: safeHands Distribution Ne, LLC
  • 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 June 8, 2023

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  • Active Ingredient

    Benzalkonium chloride, 0.13%

  • Purpose

    Antiseptic hand sanitizer

  • Uses

    To decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use

    in eyes.  In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if skin irritation develops.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Liberally apply product to skin by gently massaging until absorbed.  Supervise children in the use of this product.

  • Other Information

    Avoid extreme temperatures.

  • Inactive Ingredients

    Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate 20, Fragrance, FD&C Blue No. 1

  • Questions/Comments?

    Call toll free 888-338-1338

  • SPL UNCLASSIFIED SECTION

    safeHands®
    Next Generation Hand Sanitizer
    Kills 99.9% of germs while pampering your hands
    Learn more at: www.safehands.com

    A percentage of profits is donated to Safe Kids Worldwide
    to “keep all kids safe from preventable injuries”

    #1 Alcohol Free Brand

    Manufactured for safeHands, LLC, Boca Raton, FL
    Patent Pending 61/473 385
    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    safeHands®
    Alcohol Free
    Hand Sanitizer
    Kills 99.9% of germs.
    • Non-toxic
    • Moisturizing
    Clean Linen

    20140927 Safehands 102

  • INGREDIENTS AND APPEARANCE
    SAFEHANDS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60867-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60867-102-0252 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    2NDC:60867-102-07208 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    3NDC:60867-102-18532 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2023
    Labeler - safeHands Distribution Ne, LLC (080026877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vintage Chemical Inc116949970manufacture(60867-102)
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