FOAMING HAND- benzalkonium chloride lotion 
OptiSource International, 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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Optical Foaming Hand Sanitizer  224.000/224AA

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

Warnings

for external use only: hands

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

Rear label text

Distributed by:

OptiSource International, Inc

40 Sawgrass Drive, Bellport, NY 11713

principal display panel

Optical

Soap

Sanitizing Foaming Hand Soap

7.5 FL OZ (221 mL)

image description

FOAMING HAND 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75447-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75447-224-96222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - OptiSource International, Inc (849200159)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(75447-224)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(75447-224)

Revised: 4/2022
Document Id: 8bb1a4db-00a3-4435-900e-6a565d232629
Set id: c303f5e7-307c-407f-91f5-f92008fa3c29
Version: 9
Effective Time: 20220426
 
OptiSource International, Inc