Label: BEBAK HYGIENE HAND SANITIZER- alcohol 90% aerosol, spray

  • Category: HUMAN OTC DRUG LABEL

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 September 11, 2020

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  • Active Ingredient

    Ethanol 90.24%

  • Purpose

    Antiseptic

  • Uses

    To help reduce bacteria on skin that may cause disease.

  • Warnings

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

    DANGER: Flammable. Contents Under Pressure.

    Do not use near heat, sparks or flames. Vapors may ignite explosively and cause flash fire. Prevent build up of vapors.

    Do not smoke turn of pilot lights, stove, heaters and other sources of ignition during use and until all vapors are gone.

    Do not puncture of incinerate container. Do not expose to heat or store at temperatures above 120F.

    Use with adequate ventilation.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Spray hands thoroughly with product and rub into hands until dry.

  • STORAGE AND HANDLING

    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.

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    BEBAK HYGIENE HAND SANITIZER 
    alcohol 90% aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77462-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL135.26 mL  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77462-015-01150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/11/2020
    2NDC:77462-015-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/11/2020
    Labeler - SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI (366418499)
    Establishment
    NameAddressID/FEIBusiness Operations
    SORA KOZMETIK SANAYI TICARET ANONIM SIRKETI366418499manufacture(77462-015)
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