Label: MELLOW HAND SANITIZER 500ML ML318 01- alcohol liquid

  • 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 May 9, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Mellow hand sanitizer ML318.JPG

  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 62%(V/V) Antiseptic

  • Features

    To decrease bacteria on the skin that could cause disease.

    Recommended for repeated use

    Use anywhere without water.

    Recommended for repeated use.

    use anywhere without water.

  • Warning

    For external use only-hands

    Flammable,keep away from heat and flame

    Discontinue if skin becomes irritated and ask a doctor.

    keep out of reach of children.In case of accidental ingestion,seek professional assistance or contact a Poison Control Center immediately.

    For external use only.

    Flammable, keep away from heat and flame.

    Discontinue if skin becomes irritated and ask a doctor .

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.

  • Inactive ingredients

    Alcohol,water,Isopropyl Alcohol,Glycerin,Carbomer,Aminomethyl Propanol,Parfum,Propylene Glycol,ISOPROPYL MYRISTATE,ALOE BARBADENSIS LEAF JUICE,Tocopheryl Acetate,YELLOW 5,BLUE 1.

  • Directions

    Wet hands thoroughly with product and rub until dry without wiping

    For children under 6, use only under adult supervision.

    Not recommended for infants.

    When using this product

    keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    Do not inhale or ingest.

    Avoid contact with broken skin.

    Other information

    Do not store above 105F.

    May discolor some fabrics.

    Harmful to wood finishes and plastics.

  • Other information

  • When using this product

    Keep out of eyes,In case of contact with eyes,flush thoroughly with water.

    Do not inhale or ingest

    Avoid contact with broken skin.

  • PRINCIPAL DISPLAY PANEL

    Mellow hand sanitizer ML318

  • INGREDIENTS AND APPEARANCE
    MELLOW HAND SANITIZER 500ML ML318  01
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    PIGMENT BLUE 1 (UNII: 4SBE571RQF) 0.000024 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.5 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
    ALOE (UNII: V5VD430YW9) 0.15 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.08 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 36.307916 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    BASIC YELLOW 5 (UNII: 07BP340B4T) 0.00006 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.26 mL  in 100 mL
    Product Characteristics
    Colorgreen (transparant) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-257-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/09/2020
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - Lantern Beauty America,INC. (117371139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-257)