HAND WASH- benzalkonium chloride liquid 
Demoulas Super Markets, 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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Amber Antibacterial Hand Soap
403.002/403AC

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

Stop use and ask a doctor if

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5

Adverse reactions

DISTRIBUTED BY  DEMOLAS SUPER MARKETS, INC.

875 EAST STREET, TEWKSBURY, MA 01876

Prncipal display panel

"MORE FOR YOUR DOLLAR"

MARKET BASKET

ANTIBACTERIAL

LIQUID HAND SOAP

7.5 FL OZ (221 mL)

image description

HAND WASH 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-403
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)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SULISOBENZONE (UNII: 1W6L629B4K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53942-403-681656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2014
2NDC:53942-403-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/28/2014
3NDC:53942-403-031479 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/28/2014
Labeler - Demoulas Super Markets, Inc (007869647)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(53942-403)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(53942-403)

Revised: 6/2023
Document Id: 9c526cb3-c7ad-46f4-a344-a8653bf1c651
Set id: 458a28d5-b31d-4ffe-b23b-f32c16c7a54a
Version: 15
Effective Time: 20230615
 
Demoulas Super Markets, Inc