Identity
BioOrbil ANTIBACTERIAL HAND SOAP
Bioorbil Antibacterial Handsoap
FDA Label NDC 81396-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asilnur Gida Ve Kimya Sanayi Ticaret Limited Sirketi for the product Bioorbil Antibacterial Handsoap (NDC 81396-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding identity, active lngredient(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Lngredient(S)
Benzalkonium Chloride 0.13%
Purpose
Antimicrobial
Use(S)
For hand washing to help reduce bacteria and germs on the skin.
Warnings
- For external use only.
- Not edible. Don' t drink.
- Prolonged skin contact may cause temporary irritation.
Do Not Use
- in children less than 2 months of age.
- on open skin wounds.
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.
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.
Direction
- 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.
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.
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.
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
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