Label: CLEAN RX- ethyl alcohol solution

  • 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 August 10, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Use

    Helps decrease bacteria on skin. Recommended for repeated use.

  • Warnings

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

  • Do not apply

    around eyes

  • When using this product

    avoid contact with eyes. In case of contact flush eyes with water.

  • Stop use and ask a doctor

     If irritation or redness develop and conditions 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. Children must be supervised in use of this product.

  • Directions

    pump as needed into your palmsand throughly spread on both the hands.

  • Other information

    • Store at 20°C (68° to 77°F).
    • May discolor fabrics
  • Inactive ingredients

    acrlates/C10-30 alkyl acrylates crosspolymer, benzophenone-4, glycerin, tocopherol, water

  • Principal Display Panel

    NDC: 74235-750-02

    Clean RxTM 2 oz

    A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

    HAND SANITIZER

    Kills 99.999% of GERMS

    With Moisturizer and Vitamin E

    2 FL OZ (60 mL)

    Label

    NDC: 74235-750-08

    Clean RxTM 8 oz

    A percentage of the proceeds from this product will be donated towards the coronavirus epidemic

    HAND SANITIZER

    Kills 99.999% of GERMS

    With Moisturizer and Vitamin E

    8 FL OZ (240 mL)

    Label 1

  • INGREDIENTS AND APPEARANCE
    CLEAN RX 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74235-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    WATER (UNII: 059QF0KO0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74235-750-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
    2NDC:74235-750-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Quality Innovations Inc. (079258818)
    Registrant - Quality Innovations Inc. (079258818)
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