Label: 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 March 26, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 62.5% v/v

  • Purposes

    Antiseptic handwash

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only | Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

    Do not use

    In eyes | In children less than 2 months of age | On open skin wounds

    When using this product

    If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develops

    Stop use and ask a doctor

    If irritation or rash occurs. These may be signs of a serious condition

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry | Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    For additional information, see Safety Data Sheets (SDS) | For emergency medical information in USA and Canada, call 1-888-255-3924 | For emergency medical information worldwide, call 1-813-248-0573 | Store between 15-30°C (59-86°F) | Avoid freezing and excessive heat above 40°C (104°F)

  • Inactive Ingredients

    Water (Aqua), Propylene Glycol, Dimethicone Peg-7 Isostearate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanediol, Tocopherol Acetate, Aloe Barbadensis Leaf Juice

  • Questions?

    Toll Free 866-MEDZONE (866-633-9663) www.medzonecorp.com | info@medzonecorp.com

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    MedZone Products LLC
    9300 Marshall Dr, Ste. 200,
    Lenexa, Kansas 66215 USA

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    MedZone®
    SINCE 2001

    Hand
    Sanitizer

    GEL

    MADE IN USA

    • ANTISEPTIC HANDWASH
    • DAILY USE, TRAVEL,
      & SPORTS
    • RINSE FREE

    OF COMMON ILLNESS CAUSING GERMS
    KILLS
    99.99%
    IN 15 SECONDS

    16 FL OZ (473mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.625 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Dimethicone Peg-7 Isostearate (UNII: JVS3399FNW)  
    Aminomethyl propanediol (UNII: CZ7BU4QZJZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-604-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - MedZone Products, LLC (080083739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubot Healthcare LLC081084880MANUFACTURE(70338-604)
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