Label: SMART CARE SPRING WATER HAND SANITIZER 500ML 01- 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 December 30, 2020

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

  • Drug Facts

    54860-344-01

  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 70%V/V Antiseptic

    Use

    Health care personel hand rub to help reduce bacteria that potentially can cause disease.

  • use

    To help reduce bacteria and germs on the skin.

  • Warning

    For external 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.

  • keep out of reach of children

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

    Recommended for repeated use.

    use anywhere without water.

  • Directions

    Put a thumbnail size amount in your palm and rub your hands together briskly until dry.Children under 6 years of age should be supervised when using this product.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.

  • Inactive ingredients

    Alcohol,Aqua,Isopropyl Alcohol,Glycerin,Carbomer,Aminomethyl Propanol,Parfum,Propylene Glycol,Isopropyl Myristate,Aloe Barbadensis Leaf Water,Tocopheryl Acetate.

  • When using this product

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

    avoid contact with broken skin.

    do not inhale or ingest.

  • Other information

    Do not store above 100℉(38℃)

    May discolor some fabrics

    Harmful to wood finishes and plastics.

  • PRINCIPAL DISPLAY PANEL

     54860-344-01

  • INGREDIENTS AND APPEARANCE
    SMART CARE SPRING WATER HAND SANITIZER 500ML  01
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-344
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.1 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.068 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.12 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL  in 100 mL
    OCEAN PERCH, UNSPECIFIED (UNII: 195JQ1M6P6) 0.2 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
    Product Characteristics
    Colorwhite (transparant) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-344-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-344)