HAND WASH- benzalkonium chloride soap 
DZA Brands, LLC

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, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, PEG-120 methyl glucose dioleate, fragrance, sodium sulfate, sodium chloride, citric acid, tetrasodium EDTA, phenoxyethanol, methylisothiazolinone, yellow 5, red 4

Questions?

1-800-213-904

DISTRIBUTED BY: DZA BRANDS, LLC

2110 Executive Drive

Salisbury, NC 28147

For product questions or concerns,

contact us at 1-866-322-2439

Please include UPC number and code from package

Principal display panel

healthy accents

antibacterial hand soap

56 FL OZ (1.65 L)

image description

HAND WASH 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-403
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:55316-403-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/06/2015
2NDC:55316-403-681656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/06/2015
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-403)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-403)

Revised: 6/2023
Document Id: 67f02358-2999-44a0-9bab-81bfa8c4d1e4
Set id: 79be266f-d87d-442b-8000-bd8b8f65d96d
Version: 16
Effective Time: 20230615
 
DZA Brands, LLC