Label: HAND SANITISER- isopropyl alcohol liquid

  • 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 June 29, 2020

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  • DOSAGE & ADMINISTRATION

    ●Store between 15-30°C (59-86°F)
    ●Avoid freezing and excessive heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Glycerin，hydrogen peroxide，purified water USP

  • INDICATIONS & USAGE

    1.Place enough product on hands to cover all surfaces. Rub hands together until dry.
    2.Supervise children under 6 vears of age when using this product to avoid swallowing.

  • ACTIVE INGREDIENT

    isopropyl alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITISER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54665-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL225 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54665-001-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/29/2020
    Labeler - Jinhua Emilan Cosmetics Factory (546656775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinhua Emilan Cosmetics Factory546656775manufacture(54665-001)
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