Label: HAND SANITIZER 29ML 01- alcohol gel

  • NDC Code(s): 54860-405-01
  • 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 11, 2023

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  • Drug Facts

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  • Medical Ingredient

    Ethyl Alcohol 65% purpose：Antiseptic

  • keep out of reach of children

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

    Recommended for repeated use.

    use anywhere without water.

  • Warning

    For external use only.

    Flammable,Keep away from heat or flame.

    Discontinue use if skin becomes irritated and ask a doctor before continuing use.

    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

    Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum, sodium hydroxide, CI 19140, CI 42090, CI 14700

  • Directions

    Wet hands thoroughly with product and rub until dry without wiping.

    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

    Keep out of the eyes. In case of contact with eyes. flush thoroughly with water.
    Do not inhale or ingest.
    Avoid contact with broken skin

  • Purpose

    Antiseptic

  • Stop use and ask a doctor

    if irritation or rash occurs,these may be signs of a serious condition.

  • Use

    Anti-bacterial Hand Gel is gentle yet effective to decrease bacteria on the skin that could cause disease.
    Recommended for repeated use.
    Use anywhere without water.

  • Other information

    Do not store above 105 F.
    May discolor some fabrics.
    Harmful to wood finishes and plastics.

  • Do not use

    in children less than 2 months of age

    on open skin wounds.

  • Packaging

    PackagingPackagingPackagingPackagingdrug facts

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 29ML  01
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-405
    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
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.08 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 34.3696 mL  in 100 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 mL  in 100 mL
    D&C YELLOW NO. 11 (UNII: 44F3HYL954) 0.0001 mL  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 mL  in 100 mL
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0001 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-405-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2023
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-405)
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