FLUORISHIELD- sodium fluoride gel

FLUORISHIELD by

Drug Labeling and Warnings

FLUORISHIELD by is a Prescription medication manufactured, distributed, or labeled by Young Dental Manufacturing I, LLC, Medical Products Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactives  

Natrosol 250 (Hydroxyethyl Cellulose), Saccharin Sodium

Warning:

PRECAUTIONS: DO NOT SWALLOW. As with all medications, keep out of reach of the children

Directions 

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUORISHIELD 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0273-8011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0273-8011-01	114 g in 1 TUBE; Type 0: Not a Combination Product	09/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/21/2017

Labeler - Young Dental Manufacturing I, LLC (006309355)

Registrant - Young Dental Manufacturing I, LLC (006309355)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	manufacture(0273-8011)