SALOON ANTIBACTERIAL HAND WASH OCEAN- benzalkonium chloride solution 
TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM 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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Saloon Antibacterial Hand Wash Ocean

Drug Facts

Active Ingredient:

Benzalkonium chloride %0,13

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

  • Do not use in the eyes.

Stop use and ask a doctor if

  • Irritation and redness develop. If condition persist for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Glycerin, PEG-4 Rapeseedamide, Cocamidopropylamine Oxide, Lauramidopropylamine Oxide, Myristamidopropylamine Oxide, Lauryl Glucoside, Cetrimonium Chloride, PEG 120 Methyl Glucose Dioleate, Sodium PCA, Cocamine Oxide, Lauramine Oxide, Malic Acid, Tetrasodium EDTA, Sodium Benzoate, Potassium sorbate, Parfum, Acid Blue 9, Acid Red 33.

Package Labeling:

New Label

SALOON ANTIBACTERIAL HAND WASH OCEAN 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81608-003
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
MALIC ACID (UNII: 817L1N4CKP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81608-003-00400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2021
Labeler - TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI (643295637)

Revised: 4/2021
Document Id: c07ee239-7c47-ce5c-e053-2995a90a3dc3
Set id: bcb5af7d-2afd-7b55-e053-2995a90a9d0e
Version: 2
Effective Time: 20210421
 
TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI