ANTIBACTERIAL LIQUID HAND- benzalkonium chloride liquid 
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Antibacterial Liquid Hand Soap

ACTIVE INGREDIENT

Benzalkonium Chloride........0.13%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using this Product

Avoid contact with the eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops

or if condition persist for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help

or contact Posion Control Center right away.

Directions

-Pump into hands, wet as needed.

-Lather skin Vigorously for at least 15 seconds.

-Wash skin, rinse thoroughly and dry.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Caprylyl/Capryl Glucoside, Citric Acid, Cocamide MIPA, Cocamidopropyl Betaine, Fragrance, Glycerin, Lauryl Polyglucose, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, PEG 150 Distearate, FD&C Red #40, Tetrasodium EDTA, Water, FD&C Yellow #5

Antibacterial Liquid Hand Soap

image description
ANTIBACTERIAL LIQUID HAND 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50241-317
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50241-317-021 in 1 BOX04/15/2018
1NDC:50241-317-013.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50241-317-03209.75 kg in 1 DRUM; Type 0: Not a Combination Product04/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2018
Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
Establishment
NameAddressID/FEIBusiness Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(50241-317) , api manufacture(50241-317) , pack(50241-317)

Revised: 12/2023
Document Id: 1dc7268b-c64d-43b9-8166-0f47d9b243e9
Set id: ea0a5970-e95f-4090-bbe3-7df9e04393b5
Version: 8
Effective Time: 20231220
 
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.