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 10, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT [S]

    ALCOHOL 70% v/v

    PURPOSE

    ANTISEPTIC

  • USE[S]

    Health care personnel hand rub to help reduce baceria that potentionally 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 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.

  • DIRECTIONS

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Suprevise 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

    PEG-6 & AMP, Glycerin, Acrylates / Vinyl Isodecanoate Crosspolymer, Tocopheryl Acetate, Isopropyl Myristate, Fragrance (Parfum).

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-870
    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
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75594-870-32237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Commercial Beverage Concepts, LLC (080925174)
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