SAFEHANDS HAND SANITIZER FRAGRANCE FREE- benzalkonium chloride liquid

safeHands Hand Sanitizer by

Drug Labeling and Warnings

safeHands Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Safehands Distribution Ne, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

Warnings

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use in eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if skin/eye irritation develops.

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

Package Labeling

safeHands®                     

Hand Sanitizer

kills 99.9% of common germs

FRAGRANCE FREE

MOISTURIZING & FOAMING

ALCOHOL-FREE FORMULA

1.75 fl oz (52 mL)

NDC: 60867-150-02

Manufactured for

safeHands Distribution NE

35 Post Oak Office Park, Suite 3505   

Wilbraham, MA 01095

Call toll free

1-866-748-9990

SAFEHANDS.COM

1.75 fl oz

7 fl oz

18 fl oz

1000 mL

128 fl oz

res

INGREDIENTS AND APPEARANCE

SAFEHANDS HAND SANITIZER  FRAGRANCE FREE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60867-150
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60867-150-02	52 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2021
2	NDC: 60867-150-07	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2021
3	NDC: 60867-150-18	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2021
4	NDC: 60867-150-32	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2021
5	NDC: 60867-150-99	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/12/2021

Labeler - Safehands Distribution Ne, LLC (080026877)