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

Pouch FrontPurpose: Antimicrobial

Warning

WARNING SECTION

Warning: For External use on Hands only.

Package.Label Principal Display Panel

Pouch BackSpray Bottle FrontSpray Bottle Back

HAND SANITIZER 
hand sanitizer for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76691-1106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76691-1106-220000 g in 1 POUCH; Type 0: Not a Combination Product06/15/2020
2NDC:76691-1106-910000 g in 1 CONTAINER; Type 0: Not a Combination Product06/15/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/202005/05/2021
HAND SANITIZER 
hand sanitizer for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76691-1105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76691-1105-220000 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/2020
2NDC:76691-1105-810000 g in 1 CONTAINER; Type 0: Not a Combination Product06/15/202006/16/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/202006/16/2020
Labeler - MENTORBIO (034835234)
Registrant - MENTORBIO (034835234)
Establishment
NameAddressID/FEIBusiness Operations
MENTORBIO034835234manufacture(76691-1105)

Revised: 12/2022
Document Id: efb9c9b5-2cc6-f68d-e053-2a95a90a9657
Set id: a4094efb-70cb-d4d3-e053-2a95a90a8043
Version: 3
Effective Time: 20221213
 
MENTORBIO