Certainty® SmartShield Antimicrobial Ointment

SmartShield by

Drug Labeling and Warnings

SmartShield by is a Otc medication manufactured, distributed, or labeled by Global Health Solutions DBA Turn Therapeutics, Westwood Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMARTSHIELD- antimicrobial ointment ointment 
Global Health Solutions DBA Turn Therapeutics

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.

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Certainty® SmartShield Antimicrobial Ointment

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

*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

SMARTSHIELD 
antimicrobial ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69578-224
Route of Administration	TOPICAL, NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69578-224-30	30 g in 1 CARTON; Type 0: Not a Combination Product	10/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/04/2020	12/31/2021

Labeler - Global Health Solutions DBA Turn Therapeutics (079695890)

Registrant - Global Health Solutions DBA Turn Therapeutics (079695890)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Labs, Inc.		832280635	manufacture(69578-224) , label(69578-224)

Revised: 10/2022

Document Id: ebfa9364-5ac0-9cc4-e053-2995a90a046a

34390-5

Set id: b0e2f0e4-69bb-e492-e053-2a95a90a850e

Version: 3

Effective Time: 20221026

 

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