Label: HAND SANITIZER 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 May 20, 2020

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  • Active Ingredient

    Ethyl Alcohol 75%V/V

  • Purpose

    Antisepic

  • Use

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

  • Warnings

    For external use only.Flammable.Keep away from

    heat or flame.

  • Do not use

    in children less than 2 months of age

    on open skin wounds

  • When using this product

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

  • Stop use and ask a doctor

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

  • Keep out of reach of children

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

  • 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.

  • Other information

    Store between 15-30C(59-86F)

    Avoid freezing and excessive heat above 40C(104F)

  • Inactive ingredients

    Glycerin, Carbomer 940,Dichlorobenzyl Alcohol,Tromethamine, Grape,Aloe Andongensis Leaf,Calendula Officinalis Flower, Phenoxyethanol,Ethylhexylglycerin, Water.

  • Package Label - Principal Display Panel

    75 ml label 100 ml label 250 ml label 500 ml label 1000 ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74159-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)  
    GRAPE (UNII: 6X543N684K)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74159-002-0175 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    2NDC:74159-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    3NDC:74159-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    4NDC:74159-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    5NDC:74159-002-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Guangzhou BEAVER Cosmetic Co.,Ltd. (420020595)
    Registrant - Guangzhou BEAVER Cosmetic Co.,Ltd. (420020595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou BEAVER Cosmetic Co.,Ltd.420020595manufacture(74159-002)
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