Label: HS-70A HANDSANITIZER HANDSANITIZER- alcohol 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 June 1, 2020

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  • Drug Active

    Active IngredientsPurpose
    Ethyl Alcohol 70%v/vAntiseptic

  • WHEN USING

    Uses:

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

    Stop Use amd ask a doctor if

    • irritation or rash occurs
    • condition persists for more than 72 hours
  • DO NOT USE

    Do not use

    • For children less than 2 months of age
    • on open skin wounds
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help, or contact a Posion ControlCenter Right Away

  • PURPOSE

    Uses:

    Handsanitizer to help reduce bacteria that potentially can cause disease. For use when soap and wateer are not available

  • WARNINGS

    Warnings

    • For external use only : hands
    • Flammable keep away from heat or flame
    • Do not ingest or inhale
  • STOP USE

    Stop use and ask a doctor if

    • irritation or rash occurs
    • condition persists for more than 72 hours
  • STORAGE AND HANDLING

    • Store between 15 - 30C (59 - 86 F)
    • Avoidfreezing and storage above 40C (140F)

  • INACTIVE INGREDIENT

    Fragrance

    Glycerin

    Isopropyl Myristate

    Polyethylene Glycol/ Acrylates Copolymer

    Tocopheryl Acetate

    Water

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    HS 70A

  • INGREDIENTS AND APPEARANCE
    HS-70A HANDSANITIZER  HANDSANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74221-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74221-004-011003 L in 1 CONTAINER; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Sharp International Services, LLC (060597488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharp International Services, LLC060597488manufacture(74221-004)
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