HAND WASH- benzalkonium chloride soap 
Fred's 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 ingredients

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 reaction section

100% satisfactuion guaranteed

Questions or comments: 1-855-331-FRED (3733)

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL ROAD

MEMPHIS, TN 38118

www.fredsinc.com

principal display panel

freds

Phamacy

CLEAR

AMBER

ANTIBACTERIAL

LIQUID HAND SOAP

Original Scent

Contains Moisturizers

7.5 FL OZ (221 mL)

image description

HAND WASH 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-403
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:55315-403-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/23/2015
2NDC:55315-403-49443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2015
3NDC:55315-403-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2015
4NDC:55315-403-681656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/23/2015
Labeler - Fred's Inc (005866116)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55315-403)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55315-403)

Revised: 6/2023
Document Id: 95147820-d3bc-41a6-8548-7b9b94e282cc
Set id: 458f50bf-b542-4e8d-99e2-bb3b8cafe0a8
Version: 16
Effective Time: 20230612
 
Fred's Inc