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Certainty SmartShield FAQs

 

Certainty SmartShield Frequently Asked Questions

Overview

What is Certainty SmartShield?

Powered by Hexagen®, Certainty SmartShield is an FDA-cleared, multi-use ointment previously available by prescription only.

 

First Aid Ointment: Applied as a wound dressing to superficial cuts, burns, abrasions, and other wounds, Certainty SmartShield helps prevent infections and promote healing.

 

Nasal decolonizer: When dabbed inside the nostrils, Certainty SmartShield works to trap, eradicate, and inhibit airborne pathogens from easily entering or exiting through nasal cavity.

  • Broad spectrum protection against many viruses, bacteria, yeasts, and fungi, including influenza, MRSA, staph, and other infectious viruses.

  • Patented, first-of-its-kind extended-release drug delivery method

  • Each dose provides hours of protection with no damage to healthy cells

  • Gentle, hypoallergenic, non-irritating, and safe for sensitive skin

  • Long track record of safety and efficacy; used on thousands of patients with no adverse effects reported

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How does Certainty SmartShield work? 

When applied to the skin or nose, the petrolatum in Certainty SmartShield creates a barrier that traps pathogens (including viruses, bacteria and fungi) and helps prevent them from spreading to the body.  The antimicrobial ingredients work to eradicate the pathogens that remain, reducing the chance they will proliferate and cause illness.

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Why use a nasal decolonizer?

Mounting evidence suggests COVID-19 gains its foothold in humans by infecting certain nasal cells[1].Infected cells in the nose are also a likely source of viral shedding and spread.[2]

 

When a person is infected with a virus, they typically do not get sick right away. During what’s known as an incubation period, the virus is replicating inside the body. Once it has replicated enough to reach a critical mass
(or viral load), that person may start to show symptoms.

 

Even if they don’t  – or are recovering and feeling better – there might be a sufficient viral load in their system that they are at risk of spreading it to others, possibly by droplets and aerosolized particles produced when they cough, sneeze, sing, or even talk.[3]

 

Nasal decolonization with topical antiseptics is a common infection control practice in hospitals. One application of Certainty SmartShield has been shown to help prevent viral replication in the nose for hours.

 

When used in conjunction with other recommended protective measures – like frequent handwashing, physical distancing, and mask-wearing – Certainty SmartShield may reduce your risk of getting sick from the virus or passing it to others.

Laboratory studies show Certainty SmartShield (Hexagen) kills over 98% of human coronavirus within two hours with no damage to healthy cells.  Click here to see the lab results.

  • More than 40% dead within 2 minutes

  • More than 80% dead within 10 minutes

  • More than 98% dead in 2 hours

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How to Use Certianty SmartShield

How do I use Certainty SmartShield as a nasal decolonizer?

  1. Apply a pea-sized dollop onto a sterile swab and insert into one nostril, rotating for 30 seconds to cover
    all inside surfaces, including the tip and bottom edge of the nostril. Remove swab and discard.

  2. Using a new sterile swab, repeat step 1 for the other nostril.

  3. Press and release the sides of the nose repetitively for approximately 1 minute to facilitate transfer
    of ointment throughout.

  4. After application, do not blow nose, and avoid touching the area inside and around the nostrils.
    Do not apply other nasal products.

  5. Reapply as needed up to 3 times per day.

For use use in adults and children age 2 and older as a nasal decolonizer and/or first aid ointment.

How do I use Certainty SmartShield as a first aid ointment?

  1. Clean and dry the affected area.

  2. Using freshly washed hands, apply a thin layer of ointment.

  3. Wash hands again, and cover affected area with a sterile bandage or pad.

  4. Repeat 1 to 3 times a day or as ordered by your healthcare provider.

 

For use use in adults and children age 2 and older as a nasal decolonizer and/or first aid ointment.

 

Warnings

  • To be used in conjunction with appropriate hygiene and infection control practices.

  • Do not use concurrently with any other nasal product.

  • Do not use if you have an allergy or hypersensitivity to any of the ingredients, or if a reaction develops
    before, during, or after application.

  • Do not use as a treatment for an active or worsening infection.

  • Do not use on raw, broken, bleeding, or otherwise damaged skin/mucosal surfaces.

  • Do not use if the primary package is damaged.

  • Do not share product with or among multiple people.

  • Avoid contact with the eyes.

  • Keep out of reach of children.

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Do I still need to use a mask if I am using Certainty SmartShield?

Certainty SmartShield is not intended to replace masks where their use is recommended or required. Rather, Certainty SmartShield should be used in conjunction will appropriate hygiene and infection control practices  and can help provide added peace of mind.

Testing and Safety

Is Certainty SmartShield FDA Cleared?

Certainty SmartShield is listed in the Daily Med under an OTC monograph as an antiseptic.  The underlying product, Hexagen, has received multiple FDA clearances for indications ranging from chronic wound management to dermatitis.  Click here to learn more about Hexagen.

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How has Certainty SmartShield been tested?

In order to receive FDA clearances, Hexagen, the underlying product in Certainty SmartShield, has been extensively tested and verified in independent FDA certified labs for efficacy as well as:

  • Cytotoxicity

  • Irritation

  • Sensitization

  • Mucosal Tissue Biocompatibility/Safety

 

Click here for testing results and case studies.

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What ingredients are in Certainty SmartShield?

Active drug ingredient:
Benzalkonium chloride 0.13% (bioavailable in solution),

antimicrobial preservative: PHMB 0.5%

 

Inactive ingredients:
Petrolatum, purified water, polyhexanide/PHMB (antimicrobial preservative).

 

Certainty SmartShield is non-sterile and-contains preservatives to prevent microbial growth. Once the tube is opened, its shelf life is 28 days. Discard intact tube after printed expiration date.

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[1] Sungnak, Waradon, Ni Huang, Christophe Bécavin, Marijn Berg, and H. C. A. Network. "SARS-CoV-2 entry genes are most highly expressed in nasal goblet and ciliated cells within human airways." arXiv preprint arXiv:2003.06122 (2020).

[2] Gengler, Isabelle, James C. Wang, Marlene M. Speth, and Ahmad R. Sedaghat. "Sinonasal pathophysiology of SARS‐CoV‐2 and COVID‐19: A systematic review of the current evidence." Laryngoscope Investigative Otolaryngology (2020).

[3] CDC – Coronavirus Disease 2010 (COVID-19) – Scientific Brief: SARS-CoV-2 and Potential Airborne Transmission - https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. November 12, 2020.

© 2021 Careismatic  Brands, Inc.  All rights reserved. 

 Certainty SmartBoost, Certainty SmartShield and Certainty Technologies are Careismatic Brands.

Wash all items thoroughly after each use. Items featuring antimicrobial technology do not protect users or others against bacteria, viruses, or disease organisms. Items with fluid barrier technology are not waterproof, nor should they be used as personal protective equipment. Always follow all best practices for infection prevention.
Do not ingest Certainty SmartBoost.