SAFEHANDS HAND SANITIZER FRAGRANCE FREE- 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.

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safeHands Hand Sanitizer

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

150-02 52mL

7 fl oz

150-07 200mL

18 fl oz

150-18 500 mL

1000 mL

150-32 1000mL

128 fl oz

150-99 3785mL

res

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

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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/12/2021

Labeler - Safehands Distribution Ne, LLC (080026877)

Revised: 11/2021

Document Id: a6c855d3-fcf5-4259-80b4-37506ad24fdf

Set id: 0e7af9f7-80a1-4347-89c4-7d9c8b55d65d

Version: 4

Effective Time: 20211125

Safehands Distribution Ne, LLC