Label: SMART CARE HAND SANITIZER 2OZ 01- alcohol liquid

  • NDC Code(s): 54860-408-01
  • Packager: Shenzhen Lantern Scicence Co.,Ltd.
  • 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 12, 2023

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

  • Drug Facts
  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 62%(V/V) Antiseptic

  • Use

    To help reduce bacteria and germs on ths skin.

    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.

  • When using this product

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

    Avoid contact with broken skin.

    Do not inhale or ingest.

  • 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

    Put a thumbnail size amount in your palm and rub your hands toghther briskly until dry.Children under 6 years of age should be supervised when using SMART CARE HAND SANITIZER.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

    Do not store above 100℉(38℃)

    May discolor some fabrics

    Harmful to wood finishes and plastics.

  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SMART CARE HAND SANITIZER 2OZ  01
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-408
    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:54860-408-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2023
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - Lantern Beauty America,INC. (117371139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-408)