Label: HAND SANITIZER- alcohol gel
HAND SANITIZER- alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     78623-360-01, 78623-360-02, 78623-360-03, 78623-360-04, view more
    78623-360-05, 78623-360-06, 78623-370-01, 78623-370-02, 78623-370-03, 78623-370-04, 78623-370-05, 78623-370-06, 78623-375-01, 78623-375-02, 78623-375-03, 78623-375-04, 78623-375-05, 78623-375-06
  • Packager: ningbo fareast industry co.,ltd
  • 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 January 4, 2021

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  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    alcohol 75% v/v purpose :antiseptic

    alcohol 70% v/v purpose :antiseptic

    alcohol 60% v/v purpose :antiseptic

  • PURPOSE

  • INDICATIONS & USAGE

    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

    when using this product keep out of eyes,ears,and mouth in case of contact with eyes,rinse eyes thorough 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 control center right away.

  • STOP USE

    stop use and ask a doctor if irriation or rash occurs,these may be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children ,if swallowed, get medical help or contact a posion control center right away

  • DOSAGE & ADMINISTRATION

    place enough product on hands to cover all surface,rub hands together until dry
    supervise children under 6 years when using this product to avoid swallowing

  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

  • package label principal display panel

    30ml-70percent alcohol30ml-75percent alcohol30ml-60percent alcohol60ml-75percent alcohol60ml-70percent alcohol60ml-60percent alcohol100ml-75percent alcohol100ml percent alcohol100ml - 60percent alcohol237ml - 75percent alcohol237- 70percent alcohol237ml- 60percent alcohol500ml -75 percent alcohol500ml-70 percent alcohol500ml-60percent alcohol1000ml - 75 percent alcohol1000ml - 70percent alcohol 1000ml- 60 percent alcohol 75% alcohol concent

    1000ml NDC: 78623-375-01

    500ml NDC: 78623-375-02

    237ml NDC: 78623-375-03

    100ml NDC: 78623-375-04

    60ml NDC: 78623-375-05

    30ml NDC: 78623-375-06

    70% alcohol concent

    1000ml NDC: 78623-370-01

    500ml NDC: 78623-370-02

    237ml NDC: 78623-370-03

    100ml NDC: 78623-370-04

    60ml NDC: 78623-370-05

    30ml NDC: 78623-370-06

    60% alcohol concent

    1000ml NDC: 78623-360-01

    500ml NDC: 78623-360-02

    237ml NDC: 78623-360-03

    100ml NDC: 78623-360-04

    60ml NDC: 78623-360-05

    30ml NDC: 78623-360-06

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-370
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78623-370-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    2NDC:78623-370-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    3NDC:78623-370-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    4NDC:78623-370-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    5NDC:78623-370-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    6NDC:78623-370-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/31/2020
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-375
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78623-375-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    2NDC:78623-375-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    3NDC:78623-375-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    4NDC:78623-375-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    5NDC:78623-375-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    6NDC:78623-375-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/04/2021
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78623-360
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78623-360-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    2NDC:78623-360-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    3NDC:78623-360-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    4NDC:78623-360-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    5NDC:78623-360-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    6NDC:78623-360-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/04/2021
    Labeler - ningbo fareast industry co.,ltd (554535808)
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