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 August 3, 2020

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  • Active ingredient

    Ethyl Alcohol 70% Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.
    This product is intended for external use only

    When using this product, do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough in your palm to cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110ºF (43ºC)
    • May discolor certain fabrics or surfaces
  • Inactive Ingredients

    Water, Isopropyl Alcohol, Carbomer and Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    500 ml NDC: 79727-000-02

    500 ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79727-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79727-000-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - DELTAMED SUPPLY, LLC (117490074)
    Registrant - DELTAMED SUPPLY, LLC (117490074)
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