Label: CLINICARE PRO SURFACE SANITIZER- benzalkonium chloride, didecyl dimethyl ammonium 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 June 23, 2020

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  • Drug Facts

  • Active ingredient

    ▪ Benzalkonium Chloride 0.13%

    ▪ Didecyl dimethyl ammonium chloride 0.15%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses ▪ surface sanitizer to decrease germs

            ▪ recommended for repeated use

            ▪ for use when soap and water are not available

  • Warnings

    For surface use only

    Do not use  ▪  on open skin wounds

    When using this product  ▪  do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if  ▪  irritation and redness develop  ▪  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.

  • DOSAGE & ADMINISTRATION

    Directions  ▪ wet surface thoroughly with product and allow to dry without wiping

  • STORAGE AND HANDLING

    Other information  ▪ store between 15-30°C (59-86°F)

    ▪ avoid freezing and excessive heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Inactive ingredients  ▪ Propylene glycol (plasticizer) ▪ Laureth-4 (Surfactant) ▪ Water ▪ Glycolic acid ▪ 1-Octadecanaminium NN dimethyl (3-trihydroxysily) propyl chloride ▪ Dimethyloctadecyl (3-trimethoxysilyl) Propyl Ammonium Chloride

  • QUESTIONS

    Questions? +1-312-803-1738

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    EXTEN-DAY

    24 HOUR

    Up to 24 hours continuous protection

    Kills 99.99% of germs*

    Bonds to most surfaces

    Fast Acting 15 Second Formula

    *Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little

    as 15 seconds; it forms a non-toxic barrier with lasting effects for up to 24 hours and does not produce

    the harmful, dermatological effects associated with traditional, high alcohol based hand sanitizers

    Manufactured for: Meroven LLC - 7901 4th St. N STE 300,St.

    Petersburg, FL., 33702

    Country of origin: Spain

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CLINICARE PRO SURFACE SANITIZER 
    benzalkonium chloride, didecyl dimethyl ammonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74653-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURETH-4 (UNII: 6HQ855798J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74653-104-2180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    2NDC:74653-104-22500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    3NDC:74653-104-231000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    4NDC:74653-104-243000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    5NDC:74653-104-255000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - Meroven LLC (117473235)
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