SAFEHANDS- benzalkonium chloride liquid

safeHands by

Drug Labeling and Warnings

safeHands by is a Otc medication manufactured, distributed, or labeled by safeHands Distribution Ne, LLC, Vintage Chemical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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
Clean Linen

INGREDIENTS AND APPEARANCE

SAFEHANDS 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60867-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60867-102-02	52 mL in 1 BOTTLE	09/27/2014
2	NDC: 60867-102-07	208 mL in 1 BOTTLE	09/27/2014
3	NDC: 60867-102-18	532 mL in 1 BOTTLE	09/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/27/2014

Labeler - safeHands LLC (061206060)

Establishment
Name	Address	ID/FEI	Business Operations
Products by O2, Inc.		136932444	manufacture(60867-102)