ANTIBACTERIAL COCONUT WATER ALOE AND VITAMIN E- benzalkonium chloride liquid 
Brands International Corporation

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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Germs be Gone Antibacterial Hand Soap - Coconut water

Benzalkonium Chloride - 0.13%

Purpose - Antiseptic Skin cleanser

Effective in destroying (harmful) bacteria to provide antiseptic cleansing

Warnings For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

Keep out of reach of children :

Directions:

Lauramidopropylamine oxide, Lauryl Glucoside, PEG-150 distearate, Glycol Stearate, Perfume, PEG-7 glycerly cocoate, Cetrimonium Chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Isopropyl myristate, Tocopheryl Acetate

9101112

ANTIBACTERIAL  COCONUT WATER ALOE AND VITAMIN E
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-516
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-516-373780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
2NDC:50157-516-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
3NDC:50157-516-23236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
4NDC:50157-516-44443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/26/2021
Labeler - Brands International Corporation (243748238)
Registrant - Brands International Corporation (243748238)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(50157-516)

Revised: 1/2021
Document Id: b9e40c73-c2f6-faaa-e053-2a95a90a5c47
Set id: af70531b-b071-4dc3-8d29-b63e3b30457f
Version: 2
Effective Time: 20210127
 
Brands International Corporation