Label: PURE X DISINFECTING WIPES- ethyl alcohol, benzalkonium chloride cloth

  • 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 November 11, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 75%

    Benzalkonium Chloride 0.10%

  • Purpose

    Antiseptic

  • Indication and usage

    • For hand washing in order to sanitize skin with a 99.9% efficiency (hands must air dry)

  • Warnings

    • For external use only.

    • Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

    • Do not use if you are allergic to any of the ingredients.

    • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

    • Keep out of reach of children unless under adult supervision.

    • If swallowed, get medical help

  • Directions of use

    • Wet hands thoroughly with product and allow to dry without rinse.

    • Children under six years of age should be supervised when using this product.

  • Other Information

    • Store in a dry place away from fire.

  • Inactive Ingredients

    • Purified (RO) Water, Aloe Vera Extract

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF VIRUSES & BACTERIA

    √ Kills Salmonella, E. Coli, HA-RSV, MRSA, Staph, Strep

    √ Kills cold and flu viruses

    √ Kills antibiotic resistant bacteria

    √ Traps and lifts mess

    DAILY CLEANING

    EFFECTIVE STERILIZATION

    DEIONIZED WATER

    EXQUISITE NON WOVEN FABRIC

    DISTRIBUTED BY:

    Mansoc Corporation

    91-16 25th Avenue

    East Elmhurst, NY 11369

    Made in China

    Sanitize your hands every time!

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    PURE X DISINFECTING WIPES 
    ethyl alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80443-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80443-075-01100 in 1 CANISTER10/07/2020
    13.08 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/07/2020
    Labeler - Snapsak Ltd (055127321)
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