Safehands (Benzalkonium Chloride) Liquid [Safehands Llc] -

SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]
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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
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
Cucumber Mint

INGREDIENTS AND APPEARANCE

SAFEHANDS
benzalkonium chloride liquid

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60867-101-02	52 mL in 1 BOTTLE	09/27/2014
2	NDC:60867-101-07	208 mL in 1 BOTTLE	09/27/2014
3	NDC:60867-101-18	532 mL in 1 BOTTLE	09/27/2014

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

Labeler - safeHands LLC (061206060)

Name	Address	ID/FEI	Business Operations
Establishment
Products by O2, Inc.		136932444	manufacture(60867-101)

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