Label: HAND SANITIZER- 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 23, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • PURPOSE

  • Uses

    • antiseptic skin cleanser
    • antibacterial cleanser
    • kills harmful bacteria and germs
  • Warnings

    For external use only.

    Flammability warning: Keep away from open flame and sources of heat.

    When using this product avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    • Adults and children over 2 years: For occasional and personal domestic use.
    • Supervise children when they use this product.
    • Rub thoroughty into hands for at least 30 seconds. Allow to dry.
  • Inactive ingredients

    Aqua, Carboxymethyl cellulose, tert - butyl alcohol, denatonium benzoate

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79352-001
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79352-001-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    2NDC:79352-001-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    3NDC:79352-001-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    4NDC:79352-001-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    5NDC:79352-001-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    6NDC:79352-001-063785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - AEROQUEST, INC (883142077)
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