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 December 3, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    • With 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.

    Keep out of the reach of children unless under adult supervision. 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 in between 5°-30°C (41°-86°F)

    Avoid freezing and excessive heat above 40°C (104°F)

  • Inactive Ingredients

    Water (Aqua), Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TRADEMARK BRAND LLC
    1 Bridge Plaza N Ste 475
    Fort Lee, NJ 07024

  • PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

    Safe Choice

    TRADEMARK
    BRAND

    Zestfully Efficacious
    HAND
    SANITIZER

    KILLS 99.9% OF GERMS*

    Antibacterial

    70% ALCOHOL

    2 FL OZ (59 ML)

    PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79882-001
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79882-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
    2NDC:79882-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
    3NDC:79882-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
    4NDC:79882-001-043700 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A11/19/2020
    Labeler - Solve Together, LLC (117539166)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organikisimo, S.A. de C:V951579669MANUFACTURE(79882-001)
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