SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]

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SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]
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NDC 60867-100-02, 60867-100-07, 60867-100-18
Set ID 20cafd74-691f-45a0-b3e8-ca15a0f735ce
Category HUMAN OTC DRUG LABEL
Packager safeHands LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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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, Cocamidopropyl PG-Dimonium Chloride Phosphate, Propylene glycol, Triethylene glycol

  • 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
    Fragrance Free

    20140927 Safehands 100

  • INGREDIENTS AND APPEARANCE
    SAFEHANDS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60867-100
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60867-100-0252 mL in 1 BOTTLE09/27/2014
    2NDC:60867-100-07208 mL in 1 BOTTLE09/27/2014
    3NDC:60867-100-18532 mL in 1 BOTTLE09/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2014
    Labeler - safeHands LLC (061206060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Products by O2, Inc.136932444manufacture(60867-100)
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