Label: SANITIZED PRO MULTI-PURPOSE ANTIBACTERIAL WIPES- wipes cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 22, 2020

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  • SPL UNCLASSIFIED SECTION

    1. Hypochlorous Acid
    2. Sodium Chloride
    3. Water.
  • Active Ingredient(s)


    Hypochlorous Acid (EPA Reg# 96048-1)...........Sanitizing/Antimicrobial Agent
    Solution is on the EPA N-List N-Products with Emerging Viral Pathogens and
    Human Coronavirus claims for use against SARS CoV-2.

  • Purpose

    Sanitizing/Antimicrobial Agent

  • Use

    Decreases bacteria on skin.

  • Warnings

    For external use only.

  • Do not use

    If you are allergic to the ingredient. Avoid contact to the
    eyes and skin. May irritate eyes or sensitive skin. If contact occurs rinse
    thoroughly with water.

  • WHEN USING

    Avoid contact of eyes and skin at full strength may irritate eyes or sensitive skin. In case of eye contact immediately flush eyes with plenty of fresh water. If skin irritation occurs, wash with soap and water.

  • STOP USE

    If irritation or rash develops and
    continues for more than 72hrs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and children 2 years and over: Apply to area and
    allow to dry without wiping. Children should be supervised when using and
    those under 2 years of age ask doctor before use. Do not flush. Discard in a
    trash receptacle.

  • Other information

    Storage - Keep containers tightly closed to keep wipes from drying out.
    Keep out of sunlight and store in a cool place.

  • Inactive ingredients

    Water and Sodium Chloride

  • Package Label - Principal Display Panel

    Package.Label Principal Display PanelPackage.Label Principal Display PanelPackage.Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SANITIZED PRO MULTI-PURPOSE ANTIBACTERIAL WIPES 
    wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80546-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 16.26 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80546-001-80400 g in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    2NDC:80546-001-16800 g in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    3NDC:80546-001-502500 g in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Poseidon Technology, LLC (103470197)
    Registrant - Poseidon Technology, LLC (103470197)
    Establishment
    NameAddressID/FEIBusiness Operations
    Poseidon Technology, LLC103470197manufacture(80546-001)
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