Label: AOMI HAND SANITIZER CLEANSING PLUS- 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 April 14, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 70.0% (w/w)

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Carbomer 940, Triethanolamine, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Fragrance

  • PURPOSE

    PURPOSE: ANTISEPTIC

  • WARNINGS

    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

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

  • Uses

    Uses

    Disinfection of hands and skin

  • Directions

    Directions
    ■ Please take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

  • Other Information

    Other Information

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

  • QUESTIONS

    Questions

    www.mirfeel.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    AOMI HAND SANITIZER CLEANSING PLUS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75010-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Mirfeel Korea Co., Ltd (695004258)
    Registrant - Mirfeel Korea Co., Ltd (695004258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mirfeel Korea Co., Ltd695004258manufacture(75010-010)
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