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 18, 2020

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  • DOSAGE & ADMINISTRATION

    Store in cool&dry place

  • INACTIVE INGREDIENT

    Acrylate / C10-30 Alkyl Acrylate Crosspolymer

    Glycerol

    Amino acid

    Purified Water

  • INDICATIONS & USAGE

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • ACTIVE INGREDIENT

    Ethyl Alcoho

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.For external use only. Keep away from fire or flame.
    2.Do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.
    3.Stop use and ask a doctor if iritation or rash appears and lasts.
    4.Keep out of reach of children.

    5.Store in cool&dry place

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54586-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINO ACIDS, ESSENTIAL (UNII: N7U7BXP2OI)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code ecofinest
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54586-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/2020
    Labeler - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd. (545558488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.545558488manufacture(54586-001)
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