BIOLUSTRE ALCOHOL WIPES- ethyl alcohol cloth

Biolustre ALCOHOL WIPES by

Drug Labeling and Warnings

Biolustre ALCOHOL WIPES by is a Otc medication manufactured, distributed, or labeled by KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70%

INACTIVE INGREDIENT

Water

PURPOSE

Antiseptic

INDICATIONS & USAGE

Used for antibacterial hand skin, prevent bacteria.

WARNINGS

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

DO NOT USE

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

WHEN USING

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STORAGE AND HANDLING

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOLUSTRE ALCOHOL WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80371-101
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80371-101-01	72 g in 1 POUCH; Type 0: Not a Combination Product	08/31/2020
2	NDC: 80371-101-02	100 g in 1 POUCH; Type 0: Not a Combination Product	08/31/2020
3	NDC: 80371-101-03	400 g in 1 POUCH; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

Establishment
Name	Address	ID/FEI	Business Operations
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI		505247089	manufacture(80371-101)