Label: PURE GEL HAND SANITIZER- 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 3, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol (70% v/v)

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria that potentially can cause disease • For use when soap and water are not available.

  • Warnings

    For external use only

    Flammable. Keep away from fire or flames

    Do not use

    • In children less than 2 months of age • On open skin wounds.

    When using this product

    • Keep out of eyes, ears, and mouth
    • In case of contact with eyes, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • Irritation or redness develops. 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

    • Store between 59 – 86° F (15 -30°C)
    • Avoid freezing and excessive heat above 104° F (40°C)

  • Inactive Ingredients

    Purified water, glycerin, aculyn excel, triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Kills 99.9% of Germs

    PureGel kills germs while keeping your hands soft and supple.

    Fragrance Free

    PRODUCT OF HONDURAS

    Cleanliness is extremely important. Protect your loved ones by utilizing PureGel to kill germs and keep your hands soft and fresh.

    Our formula has proven to be highly effective to kill germs and keep our hands clean, all while promoting soft and non sticky skin.

    MaskD Health LLC, 10408 West State Road 84, Davie, FL 33324.

    1-844-308-0458     WWW.SHOPMASKDHEALTH.COM

  • Packaging

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  • INGREDIENTS AND APPEARANCE
    PURE GEL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79168-435
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACULYN EXCEL (POLYMER DISPERSION) (UNII: RD9Y6KOY5S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79168-435-0259.15 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    2NDC:79168-435-04118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    3NDC:79168-435-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    4NDC:79168-435-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    5NDC:79168-435-413785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    6NDC:79168-435-4518925 mL in 1 PAIL; Type 0: Not a Combination Product06/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2020
    Labeler - American Textile & Apparel Inc. (141249107)
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