FDA.reportPublic FDA data

BioOrbil ANTIBACTERIAL HANDSOAP

Manufacturer
ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:36

Label at a glance#

ProductBioOrbil ANTIBACTERIAL HANDSOAP
Active ingredientBENZALKONIUM CHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

Identity

STATEMENT OF IDENTITY SECTION

BioOrbil ANTIBACTERIAL HAND SOAP

IdentityIdentity

Active lngredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Active Ingredient(s)Active Ingredient(s)

Purpose

OTC - PURPOSE SECTION

Antimicrobial

PurposePurpose

Use(s)

OTC - WHEN USING SECTION

For hand washing to help reduce bacteria and germs on the skin.

Use(s)Use(s)

Warnings

WARNINGS SECTION

  • For external use only.
  • Not edible. Don' t drink.
  • Prolonged skin contact may cause temporary irritation.

​WarningsWarnings

DO NOT USE

OTC - DO NOT USE SECTION

  • in children less than 2 months of age.
  • on open skin wounds.

DO NOT USEDO NOT USE

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

When using this productWhen using this product

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop use and ask a doctorStop use and ask a doctor

Direction

INSTRUCTIONS FOR USE SECTION

  • Pump into hands,wet as needed.
  • Lather vigorously for at least 15 seconds.
  • Wash hands, rinse thoroughly and dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

DirectionDirection

Other Information

OTHER SAFETY INFORMATION

Store between 59-86°F (15-30°C). Avoid freezing and excessive heat above 104°F(40°C). May discolor certain fabrics and surfaces.

Other InformationOther Information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA, Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid, Tocopheryl Acetate, Panthenol.

Inactive IngredientsInactive Ingredients

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Usage Section

INDICATIONS & USAGE SECTION

Usage SectionUsage Section

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INSTANT EFFECT-PLUS FORMULA

Clean,Sanitize and Moisture

Free of paraben, dye and phthalates

ANTIBACTERIAL LIQUID SOAP

- Sanitizing formula to help reduce cross-contamination

- Hands feel smooth, soft and refreshed

Distributed by

PBITTS LLC

836 Foster Ave Bensenville

ILLINOIS 60106

Manufacturing Company

Asilnur Gıda ve Kimya San. Tic. Ltd. Şti.

formulated by: Aziz Aydın

MADE IN TURKEY

Packaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81396-101-502023-01-30C16284748780-1f386c649-c3ce-0266-e053-dadaa90a7c1ab8a5047b-4b61-7fc8-e053-2995a90aa201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81396-101-50BioOrbil ANTIBACTERIAL HANDSOAP500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81396-101BIOORBIL ANTIBACTERIAL HANDSOAP (BENZALKONIUM CHLORIDE) LIQUID [ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI]1Legacy NDC, 1 package rows20210131_b8a5047b-4b61-7fc8-e053-2995a90aa201.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81396-10181396-101-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
LIME OILUZH29XGA8GIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
GLYCERINPDC6A3C0OXIACT
EDETIC ACID9G34HU7RV0IACT
COCO GLUCOSIDEICS790225BIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
b8a5047b-4b62-7fc8-e053-2995a90aa201b8a5047b-4b61-7fc8-e053-2995a90aa2012021-01-11WarningsExact identifier
spl id: b8a5047b-4b62-7fc8-e053-2995a90aa201
spl set id: b8a5047b-4b61-7fc8-e053-2995a90aa201

Reported adverse events (FAERS/openFDA)#

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