Label: MELLOW HAND SANITIZER 500ML ML308-PRP 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 September 10, 2020

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  • Drug Facts

    Mellow hand sanitizer 500ml

  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 62%（V/V） Antiseptic

  • Use

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

    For use when soap and water are not available.

    Do not use

    In children less than 2 months of age.

    On open skin wounds.

    Recommended for repeated use.

    use anywhere without water.

  • Warning

    For extenal use only:hands.

    Flammable,Keep away from fire or flame.

    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.

  • 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.

  • Inactive ingredients

    Alcohol，water，Isopropyl Alcohol，Glycerin，Carbomer，Aminomethyl Propanol，Parfum，Propylene Glycol，ISOPROPYL MYRISTATE，ALOE BARBADENSIS LEAF JUICE，Tocopheryl Acetate，YELLOW No.5，FD&C BLUE No. 1.

  • 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.

    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

    Store between 15-30C

    Avoid freezing and excessive heat above 40C

  • PRINCIPAL DISPLAY PANEL

    Mellow hand sanitizer 500ml

  • INGREDIENTS AND APPEARANCE
    MELLOW HAND SANITIZER 500ML ML308-PRP  01
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-331
    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
    PIGMENT BLUE 1 (UNII: 4SBE571RQF) 0.000024 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 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) 0.1 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.12 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 36.376416 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) 0.3 mL  in 100 mL
    Product Characteristics
    Colorgreen (transparant) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-331-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - Lantern Beauty America,INC. (117371139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-331)
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