Label: ALCOHOL BASED FOAMING HAND SANITIZER- ethyl alcohol hand sanitizer 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 October 28, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

    Alcohol Based Foaming Hand Sanitizer Approval Label Labeling Information

  • Purpose

    Antiseptic, Hand Sanitizer, Antimicrobial

    See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"

  • Use

    • Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use
    • Use this product when soap and water are not available • Do not use when hands are visibly soiled

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Warnings

    For external use only.
    FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Do Not Use

    • Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.
    • See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"
  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

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

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • STOP USE

    Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • 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.

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Directions

    • • Apply sufficient product in your palm to cover hands and rub hands together briskly until dry.
      • For children under six years of age, hand sanitizer should only be used with adult supervision.

    • See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Other information

    • FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

    • See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Inactive ingredients

    Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

  • Package Label - Principal Display Panel

    1000 ml NDC: 71023-440-57

    See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

    Principal Package Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL BASED FOAMING HAND SANITIZER 
    ethyl alcohol hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-440
    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
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DIMETHICONE PEG-7 PHOSPHATE (UNII: WTP86Y84TV)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71023-440-571000 mL in 1 BAG; Type 0: Not a Combination Product02/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/15/2021
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Registrant - National Chemical Laboratories, Inc. (002289619)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Chemical Laboratories, Inc.002289619manufacture(71023-440)
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