BERKLEY JENSEN- benzalkonium chloride soap 
Apollo Health and Beauty Care

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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Berkley Jensen Antibacterial Liq Hand Soap

Active Ingredient.

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Uses

Helps eliminate bacteria on hands.

Warnings

For external use only

When using this product

Avoid contact with eyes. If this occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison center immediately.

Directions

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Lauramidopropylamide Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG – 120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200),

Principal Display Panel

PDP 11.25

BERKLEY JENSEN 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM SULFATE (UNII: 0YPR65R21J)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
BASIC YELLOW 5 (UNII: 07BP340B4T)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-350-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/15/2022
Labeler - Apollo Health and Beauty Care (201901209)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63148-350)

Revised: 8/2022
Document Id: e648a772-ffdb-df55-e053-2995a90af20a
Set id: da94f82d-42aa-41e8-e053-2995a90a8381
Version: 2
Effective Time: 20220815
 
Apollo Health and Beauty Care