Label: M. SKIN CARE GEL HAND SANITIZER- hand sanitizer 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 24, 2020

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  • DOSAGE & ADMINISTRATION

    Store at room temperature 20*. 25°C (66*F-77*F)

  • INACTIVE INGREDIENT

    Aqua, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Jojoba Wax PEG-120 Esters, Aloe Barbadensis Leaf Extract, Citric Acid, Sodium Benzoate, Potassium Sorbate, Sodium Sulfite, CI 60730, CI 17200, ISO E SUPER, HEDIONE, DIPROPYLENE GLYCOL, GALAXOLIDE, ETHYLENE BRASSILATE.

  • INDICATIONS & USAGE

    Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry.No rinsing required No towels needed.Do not use other than directed.

  • ACTIVE INGREDIENT

    Alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.Flammable, keep away from fire or fame.
    2.For external use only
    3.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    4.Stop use and ask a doctor if redness or iritation or rash appears and persists for more than 72 hours.
    5.Keep out of reach of children. If swallowed, get medical help or contact the Poison Control center right away.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    M. SKIN CARE GEL HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77218-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL262.5 mL  in 350 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77218-002-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2020
    Labeler - Palm Beach Beaute, LLC (007721815)
    Establishment
    NameAddressID/FEIBusiness Operations
    Palm Beach Beaute, LLC007721815manufacture(77218-002)
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