Hand Sanitizer by Safetec of America, Inc.

Drug Details [pdf]

HAND SANITIZER- benzalkonium chloride liquid
Safetec of America, Inc.

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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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only.

When using this product avoid contact with the eyes. In case of eye contact, flush eyes with water.

Stop use and ask doctor if irritation or redness develop, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Directions

Pump a small amount of foam in to palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry

Inactive ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 275 Gal. Container Label

NDC: 61010-8400-1

Safetec

Benzalkonium Chloride

Foaming
Hand Sanitizer
Alcohol-Free

SAFETEC OF AMERICA, Inc.
887 Kensington Ave. Buffalo, NY 14215
800-456-7077 www.safetec.com

Reorder no. 37409

275 Gal. (1,041 L)

PRINCIPAL DISPLAY PANEL – 275 Gal. Container Label

HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-8400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	1.00 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cetrimonium chloride (UNII: UC9PE95IBP)
laurtrimonium chloride (UNII: A81MSI0FIC)
dihydroxyethyl cocamine oxide (UNII: 8AR51R3BL5)
glycereth-17 cocoate (UNII: 3057VPT0KC)
citric acid monohydrate (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 61010-8400-1	1041 L in 1 CONTAINER; Type 0: Not a Combination Product	01/14/2014	04/10/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/14/2014	04/10/2014

Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019

Document Id: b8be1c79-5899-4d30-be94-f29a7570cc77

Set id: 1efab177-a41b-4cc6-9842-4cc7ebb58076

Version: 2

Effective Time: 20191206

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10