NDC 69578-224 Smartshield

Antimicrobial Ointment

NDC Product Code 69578-224

NDC 69578-224-30

Package Description: 30 g in 1 CARTON

NDC Product Information

Smartshield with NDC 69578-224 is a a human over the counter drug product labeled by Global Health Solutions Dba Turn Therapeutics. The generic name of Smartshield is antimicrobial ointment. The product's dosage form is ointment and is administered via nasal; topical form.

Labeler Name: Global Health Solutions Dba Turn Therapeutics

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Smartshield Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Nasal - Administration to the nose; administered by way of the nose.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Global Health Solutions Dba Turn Therapeutics
Labeler Code: 69578
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-04-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Smartshield Product Label Images

Smartshield Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Benzalkonium chloride (0.13% i/s*)




  • Helps to reduce pathogens that potentiallu can cause infections.


Do not ingestAsk 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 worsensSymptoms 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.


  • Adults and children 2 years and older:Skin ApplicationGently clean the affected area.Apply a small amount 1-3 times daily.May be covered with a sterile bandage.Nasal ApplicationGently 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)




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


  • SmartShieldAntimicrobial OintmentEnhanced Skin and Nasal ProtectionPowered by Hexagen®Distributed byCarismatic BrandsChatsworth, CANet wt. 30gDocumented Protection Against:MRSAStaphylococcus AureusCandida AurisHuman CoronavirusCandida AlbicansPseudomonasAntiviralAntibacterialAntifungalPetrolatum-basedNon-cytotoxicExtended-wearBe Safe.Be Smart.Be Certain.Made in USACertaintyShield.comManufactured in the USAby Turn TherapeuticsSKU: CNCAM-MULNDC: 69578-224-30

* Please review the disclaimer below.