Label: BIOLUSTRE LIQUID DISINFECTANT- alcochol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 31, 2020

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  • ACTIVE INGREDIENT

    Alcohol 70%

  • 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).

  • INACTIVE INGREDIENT

    Water

  • DOSAGE & ADMINISTRATION

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

  • PRINCIPAL DISPLAY PANEL

    Biolustre Liquid Disinfectant

  • INGREDIENTS AND APPEARANCE
    BIOLUSTRE LIQUID DISINFECTANT 
    alcochol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80371-103
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80371-103-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    2NDC:80371-103-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    3NDC:80371-103-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    4NDC:80371-103-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    5NDC:80371-103-051000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/31/2020
    6NDC:80371-103-065000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2020
    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(80371-103)
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