BIOLUSTRE LIQUID DISINFECTANT- alcochol liquid
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%

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

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

Biolustre Liquid Disinfectant

BIOLUSTRE LIQUID DISINFECTANT
alcochol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80371-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80371-103-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020
2	NDC:80371-103-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020
3	NDC:80371-103-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020
4	NDC:80371-103-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020
5	NDC:80371-103-05	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/31/2020
6	NDC:80371-103-06	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/31/2020

Labeler - KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI (505247089)

Registrant - KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI (505247089)

Name	Address	ID/FEI	Business Operations
Establishment
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI		505247089	manufacture(80371-103)