HAND WASH- benzalkonium chloride soap
Wakefern Food Corp

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

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops
condition persists for more than 72 hours

Keep out of reach of children

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

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

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

Distributed By: Wakefern Food Corp.

5000 Riverside Drive, Keasbey, NJ 08832

Call:1-800-SHOPRITE

Principal display panel

Compare to the active ingredient in ACT

ShopRite

Anticavity

FLUORIDE

RINSE

Stromg Cavity

Protection

Alcohol Free

MINT FLAVOR

ADA

Accepted

American Dental Association

IMPORTANT: Read directions for proper use

18 FL OZ (532 mL)

image description

HAND WASH
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-403
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-403-64	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2015	06/15/2023
2	NDC:41190-403-96	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/23/2015	06/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/23/2015	06/15/2023

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41190-403)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41190-403)

Revised: 6/2023

Document Id: 185cdfb0-89c8-45b9-8c82-1d95da3b9701

Set id: 94c34448-5bc5-45c1-ab9f-f6530cc0baee

Version: 14

Effective Time: 20230615

Wakefern Food Corp

Amber Antibacterial Hand Soap403.002/403AC