SAFEHANDS- benzalkonium chloride liquid 
safeHands 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.

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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, Polysorbate 20, Fragrance, FD&C Blue No. 1, FD&C Yellow No. 5

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
Cucumber Mint

20140927 Safehands 101

SAFEHANDS 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60867-101
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60867-101-0252 mL in 1 BOTTLE09/27/2014
2NDC:60867-101-07208 mL in 1 BOTTLE09/27/2014
3NDC:60867-101-18532 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(60867-101)

Revised: 9/2014
Document Id: c6c02448-eb63-4f65-9200-4673d6bf62b8
Set id: d147513b-e05d-46fd-83f2-0f329bf7aa54
Version: 1
Effective Time: 20140927
 
safeHands LLC