ANTIBACTERIAL- benzalkonium chloride 0.13% liquid 
Flex Beauty Labs

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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Antibacterial- Germout Hand Soap, Triclosan free, Kitchen Lemon

Purpose - Antibacterial

Use help eliminate bacteria on hands

Warnings 

For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

Avoid contact with eyes.In case of contact, flush and rinse with water.

Keep out of reach of children

Except under adult supervision. 

If swallowed get medical help or contact posion control right away.

Directions

Wash hands and rinse

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Coamide Methyl MEA, Fragrance, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, DMDM Hydantoin ,Cl 14700, Cl 15510.

Benzalkonium Chloride - 0.13%

lemon

ANTIBACTERIAL 
benzalkonium chloride 0.13% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-013
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)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72308-013-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/10/2020
Labeler - Flex Beauty Labs (080858917)

Revised: 7/2020
Document Id: aa19a06e-fabb-5403-e053-2995a90ad6a3
Set id: 9adce142-3a03-4732-88b0-2740c42d949f
Version: 2
Effective Time: 20200710
 
Flex Beauty Labs