Label: MOISTURIZING HAND SANITIZER PEPPERMINT- 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 August 11, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 70%

  • INACTIVE INGREDIENT

    Aqua/Water, Carbomer, Aminomethyl Propanol, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Fragrance, Aloe Barbadensis Extract, Tocopheryl Acetate, CI 16255

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only: hands

    --------------------------------------------------------------------------------------------------------

    Flammable. Keep away from fire or flame
    --------------------------------------------------------------------------------------------------------
    When using this product

    ㆍkeep out of eyes. In case of contact with eyes, flush thoroughly with water.
    ㆍavoid contact with broken skin ㆍdo not inhale or ingest
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if 

    ㆍirritation or redness develops ㆍcondition persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ㆍto decrease bacteria on the skin that could cause disease
    ㆍrecommended for repeated use

  • Directions

    ㆍwet hands thoroughly with product and allow to dry without wiping
    ㆍfor children under 6, use only under adult supervision
    ㆍnot recommended for infants
    ㆍdo not consume

  • Other Information

    ㆍstore below 110℉ (43℃) ㆍmay discolor some fabrics
    ㆍharmful to wood finishes and plastics

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING HAND SANITIZER PEPPERMINT 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol21 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AminomethylPropanol (UNII: LU49E6626Q)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75010-130-0130 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Mirfeel Korea Co., Ltd (695004258)
    Registrant - Mirfeel Korea Co., Ltd (695004258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mirfeel Korea Co., Ltd695004258manufacture(75010-130)
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