BIOLUSTRE DISPOSABLE HAND CLEANSING GEL- ethyl alcohol gel 
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE 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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Alcohol 70% v/w

Antiseptic

Used for antibacterial hand skin, prevent bacteria

For external use only. Flammable. Keep away from fire.

• Keep away from fire.
• Do not wipe your eyes.
• Do not throw into the toilet (not soluble in water).

• Please wait until the alcohol has completely evaporated after wiping.
• Before use, check whether the packaging is intact. Do not use if it is damaged.

Stop use and ask a doctor for those with alcohol allergy or sensitive skin.

Keep out of reach of children.

• Store between 15-30°C (59-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

Water, Glycerin, Carbomer, Triethanolamine

Use it as needed, after following the usage instructions. For external use only.

Biolustre Disposable Hand Cleansing Gel

BIOLUSTRE DISPOSABLE HAND CLEANSING GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80371-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80371-105-013 mL in 1 POUCH; Type 0: Not a Combination Product09/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/29/2020
Labeler - KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI (505247089)
Registrant - KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI (505247089)
Establishment
NameAddressID/FEIBusiness Operations
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI505247089manufacture(80371-105)

Revised: 9/2020
Document Id: b06a3464-7d48-8b31-e053-2995a90a9a02
Set id: b06a3464-7d47-8b31-e053-2995a90a9a02
Version: 1
Effective Time: 20200928
 
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI