ANTIBACTERIAL- benzalkonium chloride liquid 
DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI

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, Triclosan free- Germout Hand Soap- White Tea Berry

Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Use help eliminate bacteria on hands

Warnings For external use only

Causes serious eye damage. Toxic to aquatic life.Avoid release to the environment.

Dispose of contents/container in accordance with national regulations.

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.

Remove contact lenses, if present, and easy to do. Continue rinsing.

Keep out of reach of children

Except under adult supervision. DO NOT EAT DRINK.

Keep away from food,drink and animal feeding stuffs,

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

Directions

apply onto wet hands.

Lather and rinse thoeoughly.

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4,Benzyl Alcohol,Limonene.

GRAP

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78242-005
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SULISOBENZONE (UNII: 1W6L629B4K)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78242-005-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2020
Labeler - DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI (504571389)

Revised: 6/2020
Document Id: a8b0d4dc-4907-c920-e053-2a95a90a576f
Set id: 524a079b-e707-4628-9a9c-2f7575cbe6e1
Version: 3
Effective Time: 20200622
 
DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI