Label: CLEAN31- benzalkonium chloride liquid

  • 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 January 7, 2021

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Clean 31

  • Purpose

    Skin Anticeptic

  • Uses

    For hand and skin sanitizing to decrease microbes on skin

  • Warnings

    For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention

  • Stop use and ask a doctor

    If irritation or redness develops, or if condition 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.

  • Directions

    Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

  • Other Information

    Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed.

  • Inactive Ingredients

    Water, Colloidal Silicon Dioxide

  • Questions?

    email info@S3Surfaces.com

  • Alcohol-Free Formulation

    S3 Surface Protect, Quality branded Clean31 Protection, Hand Sanitizer, Sanitizes, Protects up to 4 hours, Alcohol-Free, Fragrance-free, Up to 4 hours of Protection, Kills over 99.9% of Germs

  • Hand Sanitizer Label

    Product label picture

    Clean31

  • INGREDIENTS AND APPEARANCE
    CLEAN31 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81300-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 99.67 g  in 100 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81300-100-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/08/2020
    2NDC:81300-100-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
    3NDC:81300-100-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
    4NDC:81300-100-041000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/08/2020
    5NDC:81300-100-053785.41 mL in 1 JUG; Type 0: Not a Combination Product12/08/2020
    6NDC:81300-100-0618927.1 mL in 1 PAIL; Type 0: Not a Combination Product12/08/2020
    7NDC:81300-100-07208198 mL in 1 DRUM; Type 0: Not a Combination Product12/08/2020
    8NDC:81300-100-081249000 mL in 1 CONTAINER; Type 0: Not a Combination Product12/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/08/2020
    Labeler - S3 Surface Solutions, LLC (087784389)
    Registrant - S3 Surface Solutions, LLC (087784389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Polyventive LLC116722770manufacture(81300-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guide Energy Solutions117045830manufacture(81300-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emerald 66 Enterprises LLC117386196manufacture(81300-100)
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