Label: SAFEHANDS SQUIRTS- 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 September 27, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • 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, 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
    SafeThePlanet

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

  • PRINCIPAL DISPLAY PANEL

    safeHands® Squirts® 4 Kids
    Alcohol Free
    Hand Sanitizer
    Kills 99.9% of germs.
    • Non-toxic
    • Non-flammable
    • Non-skin drying
    Cool Blue

    20140927 Safehands 104

  • INGREDIENTS AND APPEARANCE
    SAFEHANDS SQUIRTS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60867-104
    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:60867-104-0252 mL in 1 BOTTLE09/27/2014
    2NDC:60867-104-07208 mL in 1 BOTTLE09/27/2014
    3NDC:60867-104-18532 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(60867-104)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!