Label: ANTISEPTIC HAND SANITIZER- alcohol gel

  • NDC Code(s): 79992-650-01, 79992-650-05, 79992-650-12, 79992-650-14
  • Packager: Solvent Systems International
  • 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 October 22, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use
    • in children less than 2 months of age
    • on open skin wounds

    When using this product
    • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if
    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    carbomer, fragrance, glycerin, lauryl lactate, polyethylene glycol, water

  • Questions? +1-847-437-1100

    You may also report serious side effects to this phone number.
    Mon - Fri 9:00 am - 5:00 pm

  • SPL UNCLASSIFIED SECTION

    Alcohol Gel

    Manufactured by

    Solvent Systems International
    70 King Street, Elk Grove Village, IL 60007

    www.solvent-systems.com

    Made in the USA

  • Packaging

    Alcohol65

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79992-650
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79992-650-013.78 L in 1 CONTAINER; Type 0: Not a Combination Product08/24/202001/31/2024
    2NDC:79992-650-0518.9 L in 1 CONTAINER; Type 0: Not a Combination Product08/24/202001/31/2024
    3NDC:79992-650-121.9 L in 1 BOTTLE; Type 0: Not a Combination Product08/24/202001/31/2024
    4NDC:79992-650-140.95 L in 1 BOTTLE; Type 0: Not a Combination Product08/24/202001/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/202001/31/2024
    Labeler - Solvent Systems International (106926553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solvent Systems International106926553manufacture(79992-650)