Label: BLUZEN HAND SANITIZER LAVENDER- ethyl 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 September 11, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses ? hand sanitizer to help reduce bacteria on skin

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    When using this product ? do not get into eyes. In case of contact, rinse eyes thoroughly with water

    ? do not inhale or ingest

    Stop use and ask a doctor if irritation and redness develop

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ? place enough product in your palm to thoroughly cover your hands

    ? rub hands together briskly until dry

    ? supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    ? Store below 110°F (43°C)

  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water, polyethylene glycol, carbomer copolymer, fragrance

  • QUESTIONS

    Questions? 1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    CLEANSING FORMULA

    KILLS 99.9% OF GERMS

    MADE IN THE USA

    SULFATE FREE PARABEN FREE

    VEGAN, CRUELTY FREE

    SHOPBLUZEN.COM

    Distributed by: Remcoda, LLC, New York, NY, 10018

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BLUZEN HAND SANITIZER LAVENDER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79200-801
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-801-16500 mL in 1 BOTTLE, PUMP; 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 - Remcoda, Llc (117130169)
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