SAFEHANDS- benzalkonium chloride liquid 
safeHands Distribution Ne, LLC

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.

----------

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

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

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

20140927 Safehands 102

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)

Revised: 6/2023
Document Id: 9391d6ad-4552-473e-8a42-26b71846acf4
Set id: 4d7e3e0d-6884-49fa-8427-0076e2761626
Version: 2
Effective Time: 20230608
 
safeHands Distribution Ne, LLC