Label: HAND SANITIZER- ethyl alcohol aerosol, spray

  • 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 20, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

    Hydrogen Peroxide 4% Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • 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 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 Control Center right away.

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control 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

    water, glycerin, natural and artificial fragrances.

  • Package Label - Principal Display Panel

    75334-034-03
    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    75334-031-03
    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    75334-032-03
    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    75334-033-03
    Principal Display Panel

  • PRINCIPAL DISPLAY PANEL

    75334-025-03
    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75334-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE4 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT (UNII: V95R5KMY2B)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75334-031-03119 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    HAND SANITIZER 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75334-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE4 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VANILLA (UNII: Q74T35078H)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75334-032-03119 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    HAND SANITIZER 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75334-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE4 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VANILLIN (UNII: CHI530446X)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75334-033-03119 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    HAND SANITIZER 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75334-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE4 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75334-034-03119 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    HAND SANITIZER 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75334-035
    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
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75334-035-03119 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Singtech Inc. (050391348)
    Establishment
    NameAddressID/FEIBusiness Operations
    Singtech Inc.050391348relabel(75334-031)