Label: QUANTUM MEDIUM VISCOSITY GEL 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 September 4, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Alcohol 72% v/v

  • PURPOSE

    Antiseptic

  • USE

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.
    Do not use:
    · On children less than two 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 maybe signs of a serious condition.

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using to avoid swallowing.

  • STORAGE AND HANDLING

    OTHER INFORMATION Store between 15°-30°C (59° - 86°F)
    Avoid freezing and excessive heat above 40°C (104°F) 

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS ethyl acrylate copolymer*, ethyl methacrylate*, fragrance (parfum), glycerin, purified water USP, triethanolamine

    *Contains one of more of these ingredients

  • SPL UNCLASSIFIED SECTION

    MADE IN THE USA · DUNS (10-906-5471) 

    TOPICAL ANTISEPTIC GEL HAND SANITIZER
    KILLS 99.9% OF ILLNESS CAUSING GERMS

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    QUANTUM MEDIUM VISCOSITY GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79413-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL ACRYLATE (UNII: 71E6178C9T)  
    ETHYL METHACRYLATE (UNII: 80F70CLT4O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79413-206-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    2NDC:79413-206-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    3NDC:79413-206-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    4NDC:79413-206-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    5NDC:79413-206-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    6NDC:79413-206-883785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - Quantum Valve And Oilfield Solutions, Llc (109065471)
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