Label: SMARTSHIELD- antimicrobial ointment ointment
- NDC Code(s): 69578-224-30
- Packager: Global Health Solutions DBA Turn Therapeutics
- Category: HUMAN OTC DRUG LABEL
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.
Updated October 4, 2020
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- Drug Facts
- Active Ingredient
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
Adults and children 2 years and older:
- Gently clean the affected area.
- Apply a small amount 1-3 times daily.
- May be covered with a sterile bandage.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
Enhanced Skin and Nasal Protection
Powered by Hexagen®
Net wt. 30g
Documented Protection Against:
- Staphylococcus Aureus
- Candida Auris
- Human Coronavirus
- Candida Albicans
Made in USA
Manufactured in the USA
by Turn Therapeutics
INGREDIENTS AND APPEARANCE
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 Labeler - Global Health Solutions DBA Turn Therapeutics (079695890) Registrant - Global Health Solutions DBA Turn Therapeutics (079695890) Establishment Name Address ID/FEI Business Operations Global Health Solutions DBA Turn Therapeutics 079695890 manufacture(69578-224) , label(69578-224)