Label: CLEAN ALL 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 December 1, 2020

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

  • Active Ingredient

    Active ingredient

    Active ingredient 72% Ethyl Alcohol

  • Purpose

    Antiseptic, Hand Sanitizer Purpose

  • Use

    Uses

    help reduce bacteria on hands.

    when soap and water are not available.

  • Warnings

    Warnings

    For external use only.

    Flammable. Keep away from heat or flame

    Do not use on open wounds

    avoid eyes, ears and mouth. In case of contact rinse thoroughly with water

    Stop and ask doctor

    Stop and Ask doctor

    irritation or rash occurs

    you may report side effects to 1-800-315-4467

    Keep out of reach of children

    Keep outof reach of children

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

  • Directions

    • 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

    Other Information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Inactive Ingredients

    acrylate polyymer, bittering agent, fragrance, glycerin, hydrogen peroxide, polyethylene glycol, water

  • Questions

    Questions+

    Questions? 1-800-315-4467, Monday through Friday 8am-5pm EST

  • Package Label - Principal Display Panel

    Front label panel

  • INGREDIENTS AND APPEARANCE
    CLEAN ALL GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75660-023
    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
    FRAGRANCE MINT ORC2000774 (UNII: G7LK3FFB99) 0.01 mL  in 100 mL
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 1.5 mL  in 100 mL
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.01 mL  in 100 mL
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 0.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.35 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.18 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 24.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75660-023-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Solvents and Petroleum Service, Inc (013277454)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clean All117505240manufacture(75660-023)