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 October 13, 2020

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  • Active Ingredient

    Ethyl Alcohol

  • Purpose

    Antiseptic

  • Uses

    to reducebacteria on hands when soap and water are not available

  • Warnings

    f for external use only

    or external use only

    flammable, keepaway from heat and flame

    do not use on open wounds

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

    Stop and ask doctor if

    if irritation occurs

    if irritation occurs

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

    Keepoutof reach of children

    If swallowed get medical help or contact the Pioson 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 between 59-86F (15-30C) Avoid freezing 32 F and excessive heat above 140F (40C)

  • Inactive ingredients

    inactive ingredients

  • Questions

    1-800-315-4467 Monday through Friday 8am to 5pm EST

  • Package Label - Principal Display Panel

    Front Panel 75660-104-01

  • INGREDIENTS AND APPEARANCE
    CLEAN ALL GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75660-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 2 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) 30.96 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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75660-104-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    2NDC:75660-104-044 in 1 BOX10/13/2020
    2NDC:75660-104-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:75660-104-0518927.05 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    4NDC:75660-104-066 in 1 BOX10/13/2020
    4NDC:75660-104-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:75660-104-44118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    6NDC:75660-104-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    7NDC:75660-104-16473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    8NDC:75660-104-259463.52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/13/2020
    Labeler - Solvents and Petroleum Inc (013277454)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clean All117505240manufacture(75660-104)
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