Hand Sanitizer by MENTORBIO Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MENTORBIO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer for solution 
MENTORBIO

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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Hand Sanitizer

OTC - ACIVE INGREDIENT SECTON

ACTIVE INGREDIENT

Active Ingredients: Benzalkonium Chloride 0.10%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients: purified water, glycerin, Guar Gum

Dosage & Administration Section

Dosage & Administration Section

place on palms of hands, rub hands together briskly until hands dry.

Indications & Usage Section

Hand Sanitizer to help reduce bacteria on skin that could cause disease

Keep Out of Reach of Children

OTC_ KEEP OUT OF REACH OF CHILDREN

Purpose Section

Purpose: Antimicrobial

Warning

WARNING SECTION

Warning: For External use on Hands only.

Package.Label Principal Display Panel

HAND SANITIZER 
hand sanitizer for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76691-1106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)	1 g  in 100 g
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)	95 g  in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76691-1106-2	20000 g in 1 POUCH; Type 0: Not a Combination Product	06/15/2020
2	NDC: 76691-1106-9	10000 g in 1 CONTAINER; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020	05/05/2021

HAND SANITIZER 
hand sanitizer for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76691-1105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)	1 g  in 100 g
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)	95 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76691-1105-2	20000 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/15/2020
2	NDC: 76691-1105-8	10000 g in 1 CONTAINER; Type 0: Not a Combination Product	06/15/2020	06/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020	06/16/2020

Labeler - MENTORBIO (034835234)

Registrant - MENTORBIO (034835234)

Establishment
Name	Address	ID/FEI	Business Operations
MENTORBIO		034835234	manufacture(76691-1105)

Revised: 12/2022

Document Id: efb9c9b5-2cc6-f68d-e053-2a95a90a9657

34390-5

Set id: a4094efb-70cb-d4d3-e053-2a95a90a8043

Version: 3

Effective Time: 20221213