Label: HAND SANITIZER 29ML 01- alcohol liquid

  • NDC Code(s): 54860-412-01
  • 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 22, 2023

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

  • Drug Facts
  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 65%(V/V) Antiseptic

    Use

    Hand sanitizer helps to reduce bacteria that potentially can cause disease.For use when soap and water are not available.

  • Use(s)

    To decrease bacteria on the skin that could cause disease.Recommended for repeated use.

  • Warning

    For external use only-hands

    Flammable.Keep away from heat and 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

    In case of accidental ingestion,seek professional assistant or contact a Poison Control Center immediately.

    Recommended for repeated use.

    use anywhere without water.

  • Inactive ingredients

    Water(Aqua),Carbomer,Aminomethyl Propanol,Parfum,BLUE 1,RED 33,RED 4.

  • Directions

    Wet hands thoroughly with product and rub until dry without wiping.Children under 6,use only with adult supervision.

    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.

  • When using this product

    Do not use in or near eyes,In case of eye contact ,flush eyes thoroughly with water. Discontinue if skin becomes irritated and ask for a doctor.

  • Other information

    store below 105℉

    May discolor some fabrics and surfaces.

  • Purpose

    Antiseptic

  • Packaging
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 29ML  01
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.0001 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 34.73945 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.26 mL  in 100 mL
    FD&C RED NO. 4 (UNII: X3W0AM1JLX) 0.0002 mL  in 100 mL
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.00015 mL  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-412-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/23/2023
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - Lantern Beauty America,INC. (117371139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-412)