Label: HAND SANITIZER CITRUS BLEND- 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 17, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 62% v/v

  • Purposes

    Antiseptic

  • Uses:

    for handwashing to decrease bacteria on the skin when water is not available

  • Warnings:

    For external use only | Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge | Do not swallow

  • Do not use:

    In eyes | Keep out of reach of children | On open skin wounds

  • KEEP OUT OF REACH OF CHILDREN

  • 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Apply product onto hands, spread thoroughly and rub dry.

  • Inactive Ingredients:

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Glycerin, Citrus Sinensis (Sweet Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Carbomer, Triethanolamine.

  • Other:

    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)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY

    MedZone Products LLC

    9300 Marshall Dr, Ste. 200,

    Lenexa, Kansas 66215 USA

  • Questions?

    Toll Free 866-633-9663

    www.medzonecorp.com | info@medzonecorp.com

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    MedZone ®

    SINCE 2001

    Hand Sanitizer

    GEL

    -CITRUS BLEND-

    2 FL OZ (59mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER CITRUS BLEND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-606-2259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/17/2020
    Labeler - MedZone Products, LLC (080083739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Our Babylon LLC105266218manufacture(70338-606)
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