Label: OSSION HAND SANITIZER- ethanol aerosol

  • 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 June 18, 2020

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  • Active Ingredient

    Ethanol 90.24%

  • Purpose

    Antiseptic

  • Use

    It is used for local disinfection of hands and skin. It is effective against microbes and bacteria. It provides easiness and hygiene in at home, at work, in crowded environments.

  • Warnings

    For external use only.

    DANGER: Flammable. Contents Under Pressure.

    Do not use near heat, sparks, or flames. Vapors may ignite explosively & cause flash fire. Prevent build-up of vapors. Do not smoke. Turn off pilot light, stoves, heaters, and other sources of ignition during use and until all vapors are gone. Do not puncture or incinerate container. Do not expose to heat or store at temperatures about 120F. Use with adequate ventilation.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops.

  • WHEN USING

    Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical attention.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Keep out of reach of children and pets: Children under 6 years age should be supervised by an adult when using. If swallowed, get medical help or contact your Poison Control Center right away.

  • Directions

    Take a suffiicent amount in your palm and spread over the entirety of your hand and fingers. Wait for about 30 seconds for your hands to dry.

  • Other information

    Store at room temperature or in a cool place.

  • Inactive ingredients

    Water, Panthenol (Vitamin B5), Glycerol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis (Aloe Vera) Leaf Juice.

  • Package Label - Principal Display Panel

    Ossion

  • INGREDIENTS AND APPEARANCE
    OSSION HAND SANITIZER 
    ethanol aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77462-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL90.24 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77462-002-05150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2020
    Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)
    Establishment
    NameAddressID/FEIBusiness Operations
    SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI366418499manufacture(77462-002)
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