Label: BIOSS HAND SANITIZER- alcohol gel

  • 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 May 19, 2020

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  • DRUG FACTS

  • Active ingredient

    Ethyl alcohol 75%

    Purpose

    Antiseptic skin cleanser

  • USES

    Effective in killing bacteria (harmful) to provide an antiseptic cleaning. For personal hand hygiene to prevent the spread of bacteria.

  • WARNINGS

    For external use only.

    Flammable. Keep away from heat and flame.

    When using this product

    avoid contact with eyes. In case of contact, immediately flush eyes with water.

    Stop use and consult a health care practitioner if

    irritation or redness develops.

    Keep out of reach of children

    Do not use on children/infants under 2 years old (except on the advice of a doctor).

  • DIRECTION

    For occasional use for personal household use. Rub well for at least 30 seconds. Let dry.

  • OTHER INFORMATION

    Store at 20°C (68° to 77°F) cool place.

  • INACTIVE INGREDIENTS

    Acrylates/c10-30, Alkyl Acrylate Crosspolymer, Triethanolamine, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Lemon oil. 

  • QUESTIONS?

    1-866-795-8481

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    BIOSS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77134-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77134-000-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2020
    Labeler - Bioss Inc. (204091602)
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