Label: BLUZEN HAND SANITIZER KIT- ethyl alcohol kit

  • 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 July 2, 2020

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  • BluZen Hand Sanitizer-Unscented

    Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • Store below 104ºF (40ºC)
  • Inactive ingredients

    water, aloe barbadensis leaf juice, glycerin

  • Questions?

    1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING FORMULA WITH ALOE VERA

    UNSCENTED

    KILLS 99.9% OF GERMS

    SHOPBLUZEN.COM

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

    SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

  • BluZen Hand Sanitizer-Mint

    Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • Store below 104ºF (40ºC)
  • Inactive ingredients

    water, aloe barbadensis leaf juice, glycerin, mentha piperita (peppermint) oil

  • Questions?

    1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING FORMULA WITH ALOE VERA

    MINT

    KILLS 99.9% OF GERMS

    SHOPBLUZEN.COM

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

    SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

  • BluZen Hand Sanitizer-Lemon

    Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • Store below 104ºF (40ºC)
  • Inactive ingredients

    water, aloe barbadensis leaf juice, glycerin, fragrance

  • Questions?

    1-800-777-1603

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING FORMULA WITH ALOE VERA

    CITRUS

    KILLS 99.9% OF GERMS

    SHOPBLUZEN.COM

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

    SULFATE FREE * PARABEN FREE * VEGAN, CRUELTY FREE * MADE IN THE USA

  • KIT LABEL

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  • KIT COMPONENTS LABEL

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  • INGREDIENTS AND APPEARANCE
    BLUZEN HAND SANITIZER KIT 
    ethyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79200-300
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-300-021 in 1 KIT; Type 0: Not a Combination Product07/02/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, SPRAY 60 mL
    Part 21 BOTTLE, SPRAY 60 mL
    Part 31 BOTTLE, SPRAY 60 mL
    Part 1 of 3
    BLUZEN HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Item Code (Source)NDC:79200-200
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-200-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Part 2 of 3
    BLUZEN HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Item Code (Source)NDC:79200-202
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-202-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Part 3 of 3
    BLUZEN HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Item Code (Source)NDC:79200-203
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79200-203-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Labeler - Remcoda, Llc (117130169)
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