Label: HAND SANITIZER 29ML 02- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 January 27, 2021

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  • Drug Facts

     54860-340-01

  • Active Ingredient

    Active Ingredient Purpose

    Ethyl Alcohol 62%(V/V) Antiseptic

  • keep out of reach of children

    If swallowed,get medical help or contact a Poison Control Center right away at 1-800-222-1222

    Recommended for repeated use.

    use anywhere without water.

  • Warning

    For external use only,Flammable,Keep away from heat 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.

  • Inactive ingredients

    Aminomethyl propanol,Water,Carbomer,Deatonium Benzoate,Glycerin,Parfum,Propylene glycol.

  • 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.

  • When using this product

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

  • Purpose

    Antiseptic

  • Stop use and ask a doctor

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

  • Use

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

  • Other information

    Store between 15-30C(59-86F).Avoid freezing or excessive heat above 40C(104F).

  • Do not use

    in children less than 2 months of age

    on open skin wounds.

  • PRINCIPAL DISPLAY PANEL

     54860-340-01.

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 29ML  02
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-347
    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
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.28 mL  in 100 mL
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.0005 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 mL  in 100 mL
    LEMON (UNII: 24RS0A988O) 0.1 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 37.3195 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    Product Characteristics
    Colorwhite (transparant) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-347-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/28/2021
    Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
    Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Greater Pacific Industries,Inc.962000253label(54860-347)