SafeHands Alcohol Free Hand Sanitizer Unscented

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]

SAFEHANDS HAND SANITIZER UNSCENTED- benzalkonium chloride spray 
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 Alcohol Free Hand Sanitizer Unscented

Active Ingredient

Benzalkonium chloride, 0.13%

Purpose

Antiseptic hand sanitizer

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

Package Labeling

safeHands®                     
Alcohol Free
Hand Sanitizer

Kills 99.9% of germs
 Unscented

NDC: 60867-110-02

2 fl oz (59 mL)

Manufactured for safeHands

Wilbraham, MA 01095

1-866-748-9990

www.safehands.com

2 fl oz

110-02 2 oz

8 fl oz

110-08 8 oz

res

SAFEHANDS HAND SANITIZER  UNSCENTED
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60867-110
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60867-110-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/12/2021
2NDC: 60867-110-08237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/27/201412/31/2023
Labeler - Safehands Distribution Ne, LLC (080026877)

Revised: 6/2023
Document Id: b8d9f606-6b46-41b7-8de3-bc6b2ecd1c7b
Set id: bb688325-7cff-4f2c-8c2d-32dc92945fb5
Version: 4
Effective Time: 20230609