Label: BLUZEN HAND SANITIZER- ethyl alcohol gel

  • 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 June 30, 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

    water, aloe barbadensis leaf juice, glycerin, carbomer, lavandula hybrida(lavandin) oil, triethanolamine

  • QUESTIONS

    Questions? 1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING FORMULA WITH ALOE VERA

    LAVENDER

    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 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79200-101
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-101-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - Remcoda, Llc (117130169)
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