BIOORBIL ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid 
ASILNUR GIDA VE KIMYA SANAYI 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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Identity

BioOrbil ANTIBACTERIAL HAND SOAP

Identity

Active lngredient(s)

Benzalkonium Chloride 0.13%

Active Ingredient(s)

Purpose

Antimicrobial

Purpose

Use(s)

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

Use(s)

Warnings

Warnings

DO NOT USE

DO NOT USE

When using this product

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 product

Stop use and ask a doctor

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

Stop use and ask a doctor

Keep out of reach of children

Direction

Direction

Other 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 Information

Inactive Ingredients

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 Ingredients

Dosage and Administration

Dosage and Administration

Usage Section

Usage Section

Packaging

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

Packaging

BIOORBIL ANTIBACTERIAL HANDSOAP 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81396-101
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LIME OIL (UNII: UZH29XGA8G)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETIC ACID (UNII: 9G34HU7RV0)  
COCO GLUCOSIDE (UNII: ICS790225B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81396-101-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/31/2021
Labeler - ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI (503002931)
Establishment
NameAddressID/FEIBusiness Operations
ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI503002931manufacture(81396-101)

Revised: 1/2021
Document Id: b8a5047b-4b62-7fc8-e053-2995a90aa201
Set id: b8a5047b-4b61-7fc8-e053-2995a90aa201
Version: 1
Effective Time: 20210111
 
ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI