Label: AOMI HAND SANITIZER- alcohol spray

  • 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 June 4, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 70.0% (w/w)

  • INACTIVE INGREDIENT

    Water, Glycerin, Fragrance, Cymbopogon Citratus Extract, Anthemis Nobilis Flower Extract, Aspalathus Linearis Extract, Melaleuca Alternifolia(Tea Tree)Leaf Extract

  • PURPOSE

    ANTISEPTIC

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    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 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.

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

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

  • QUESTIONS

    www.mirfeel.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    AOMI HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75010-040-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - Mirfeel Korea Co., Ltd (695004258)
    Registrant - Mirfeel Korea Co., Ltd (695004258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mirfeel Korea Co., Ltd695004258manufacture(75010-040)
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