Label: CLEAN SUPPLY- 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 July 27, 2022

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  • Active Ingredient

    Ethyl Alcohol 80% v/v.

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

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

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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 may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

  • Directions

    • Put enough product inthe palm to cover your hand and rub hands together briskly until dry.
    • 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).
    • May discolor certain fabricsor surfaces.
  • Inactive ingredients

    Glycerin, Hydrogen Peroxide, Acrylates Copolymer, Propylene Glycol, Trolamine, Tocopheryl Acetate, Deionized Water.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    CLEAN SUPPLY 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80366-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80366-002-013 mL in 1 PACKET; Type 0: Not a Combination Product10/01/2020
    2NDC:80366-002-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
    3NDC:80366-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    4NDC:80366-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    5NDC:80366-002-051893 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    6NDC:80366-002-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2020
    Labeler - Environmental Applied Technology Corporation (079310895)
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