Label: SAFEHANDS HAND SANITIZER- 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 November 25, 2021

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  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin

  • Warnings

    For external use only.

    Keep out of reach of children.

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

    Do not use in eyes.

    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if skin/eye irritation develops.

  • 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

  • Package Labeling

    safeHands®                     

    Hand Sanitizer

    kills 99.9% of common germs

    BIRTHDAY CAKE

    MOISTURIZING & FOAMING

    ALCOHOL-FREE FORMULA

    No Parabens,

    Sulfates or Phthalates

    1.75 fl oz (52 mL)

    NDC 60867-300-02

    Manufactured for

    safeHands Distribution NE

    35 Post Oak Office Park, Suite 3505   

    Wilbraham, MA 01095

    Call toll free

    1-866-748-9990

    SAFEHANDS.COM

    1.75 fl oz

    300-02 52mL

    res

  • INGREDIENTS AND APPEARANCE
    SAFEHANDS HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60867-300
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60867-300-0252 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2014
    Labeler - Safehands Distribution Ne, LLC (080026877)
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