Label: EMU HAND SANITIZER MIST MINT- alcohol spray

  • NDC Code(s): 80464-1004-1
  • Packager: Everyone Must Use, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Purpose

    Antiseptic, Hand Sanitizer

  • Drug Facts

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

    Active IngredientPurpose
    Ethyl Alcohol 62%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 heat or flame. | Contents under pressure.

    Do not use

    on children less than 2 months of age. Do not use 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 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 childrenunder 6 years of age to avoid swallowing.

  • Other information

    Store between 15°-30° C (59°-86°F)

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Purified Water, Tocopheryl Acetate

  • Questions or comments?

    1-800-250-4643

  • Package Label - Principal Display Panel

    Net Wt 2.2 FL OZ (62.4g) NDC: 80464-1004-1

    label

  • INGREDIENTS AND APPEARANCE
    EMU HAND SANITIZER MIST MINT 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80464-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80464-1004-162.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/25/2020
    Labeler - Everyone Must Use, LLC (117650280)
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