FDA.reportPublic FDA data

Saloon Antibacterial Hand Wash Ocean

Manufacturer
TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI
Effective date
2021-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:52

Label at a glance#

ProductSaloon Antibacterial Hand Wash Ocean
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Wet hands and forearms. Apply 5 milliliters (2 full pumps) to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and repeat.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride %0,13

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not use in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands and forearms. Apply 5 milliliters (2 full pumps) to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and repeat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New LabelNew Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81608-003-002024-01-30C16284748780-11030e365-1941-111a-e063-dadaa90a10e2Saloon Antibacterial Hand Wash Ocean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81608-003-00Saloon Antibacterial Hand Wash Ocean400 mL in 1 BOTTLE, PUMPSOLUTION4002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81608-003SALOON ANTIBACTERIAL HAND WASH OCEAN (BENZALKONIUM CHLORIDE) SOLUTION [TIBET ITHALAT IHRACAT VE KOZMETIK SANAYI ANONIM SIRKETI]2Legacy NDC, 1 package rows20210422_bcb5af7d-2afd-7b55-e053-2995a90a9d0e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81608-00381608-003-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-4 RAPESEEDAMIDE89575CN928IACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
COCAMINE OXIDEQWA2IZI6FIIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
MALIC ACID817L1N4CKPIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
LIMONENE, (+)-GFD7C86Q1WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c07ee239-7c47-ce5c-e053-2995a90a3dc3bcb5af7d-2afd-7b55-e053-2995a90a9d0e2021-04-21WarningsExact identifier
spl id: c07ee239-7c47-ce5c-e053-2995a90a3dc3
spl set id: bcb5af7d-2afd-7b55-e053-2995a90a9d0e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.