Safety and Dosing

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.

 

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.

What ingredients are in Certainty SmartShield?

Active drug ingredients: 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.

Dosing Information and Safety

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.

 

​ 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.

© 2021 Careismatic  Brands, Inc.  All rights reserved.  Certainty SmartBoost, Certainty SmartShield and Certainty Technologies are Careismatic Brands.

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