Certainty® SmartShield Antimicrobial Ointment

Manufacturer
Global Health Solutions DBA Turn Therapeutics | Westwood Labs, Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:36

Label at a glance#

ProductSmartShield
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Helps to reduce pathogens that potentiallu can cause infections.

Dosage and administration

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 n...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride (0.13% i/s*)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Helps to reduce pathogens that potentiallu can cause infections.

Warnings

WARNINGS SECTION

Do not ingest

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Petrolatum, Purified Water, PHMB (antimicrobial preservative)

Questions?

OTC - QUESTIONS SECTION

833-871-2100

SPL UNCLASSIFIED SECTION

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

Certainty®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonCertainty Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69578-22469578-224-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebfa9364-5ac0-9cc4-e053-2995a90a046ab0e2f0e4-69bb-e492-e053-2a95a90a850e2022-10-26WarningsExact identifier
spl set id: b0e2f0e4-69bb-e492-e053-2a95a90a850e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.