Label: SMARTSHIELD- antimicrobial ointment ointment

  • NDC Code(s): 69578-224-30
  • Packager: Global Health Solutions DBA Turn Therapeutics
  • 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 October 4, 2020

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

  • Drug Facts

  • Active Ingredient

    Benzalkonium chloride (0.13% i/s*)

  • Purpose

    Antiseptic

  • Uses

    • Helps to reduce pathogens that potentiallu can cause infections.
  • Warnings

    Do not ingest

    Ask a doctor before use if you have Signs of an existing infection

  • When using this product

    • Do not use in or near the eyes.
    • Do not use if you have a history of allergy to any of the ingredients.
    • Do no use concurrently with other products on the same application site.

  • Stop use and ask a doctor

    • If condition worsens
    • Symptoms persist for more than 7 days, or clear up and occur again within a few days.
  • 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 older:

    Skin Application

    • Gently clean the affected area.
    • Apply a small amount 1-3 times daily.
    • May be covered with a sterile bandage.

    Nasal Application

    • Gently clean the inside of both nostrils, including tip(s).
    • Apply a small amount of ointment to a sterile swab and insert into the nostril.
    • Rotate swab for 10-15 seconds to cover all surfaces.
    • Repeat process for other nostril with a new, sterile swab.
    • Do not blow nose.
    • May be used up to 2-3 times per day.
  • Other Information

    Avoid excessive heat.

  • Inactive ingredients

    USP Petrolatum, Purified Water, PHMB (antimicrobial preservative)

  • Questions?

    833-871-2100

  • SPL UNCLASSIFIED SECTION

    *Patented liquid-in-oil technology. Percentage reflective of active ingredient in solution.

  • Certainty®

    SmartShield

    Antimicrobial Ointment

    Enhanced Skin and Nasal Protection

    Powered by Hexagen®

    Distributed by

    Carismatic Brands

    Chatsworth, CA

    Net wt. 30g

    Documented Protection Against:

    • MRSA
    • Staphylococcus Aureus
    • Candida Auris
    • Human Coronavirus
    • Candida Albicans
    • Pseudomonas

    Antiviral

    Antibacterial

    Antifungal

    Petrolatum-based

    Non-cytotoxic

    Extended-wear

    Be Safe.

    Be Smart.

    Be Certain.

    Made in USA

    CertaintyShield.com

    Manufactured in the USA

    by Turn Therapeutics

    SKU: CNCAM-MUL

    NDC: 69578-224-30

    Certainty Carton

  • INGREDIENTS AND APPEARANCE
    SMARTSHIELD 
    antimicrobial ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69578-224
    Route of AdministrationTOPICAL, NASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69578-224-3030 g in 1 CARTON; Type 0: Not a Combination Product10/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/04/2020
    Labeler - Global Health Solutions DBA Turn Therapeutics (079695890)
    Registrant - Global Health Solutions DBA Turn Therapeutics (079695890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Health Solutions DBA Turn Therapeutics079695890manufacture(69578-224) , label(69578-224)