Label: SANISMART 2- 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 March 14, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses   •For hand washing to decrease bacteria on the skin

             •Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes

    thoroughly with water.

    Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

    than 72 hours.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions   •Pump a small amount of foam into palm of hand.

    •Rub thoroughly over all surfaces of both hands for 15 seconds.   •Rinse with potable water.

  • INACTIVE INGREDIENT

    Inactive ingredients  Water (Aqua), coco-glucoside, laurtrimonium chloride,

    coamidopropylamine oxide, citric acid

  • QUESTIONS

    Questions or comments? 781-803-7800   •info@registeredchemicals.com

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SANISMART 2 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72130-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72130-002-021250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2018
    2NDC:72130-002-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2018
    Labeler - Registered Chemicals Corporation (046652831)