FLUORISHIELD- sodium fluoride gel 
Young Dental Manufacturing I, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

flourshield

FLUORISHIELD 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8011
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion11 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8011-01114 g in 1 TUBE; Type 0: Not a Combination Product09/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/21/2017
Labeler - Young Dental Manufacturing I, LLC (006309355)
Registrant - Young Dental Manufacturing I, LLC (006309355)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302manufacture(0273-8011)

Revised: 12/2018
Document Id: 93cf110a-e80f-47c4-bf14-2d7bc0aa3bad
Set id: dbba58a0-ce17-4fc0-ba81-625d78c1a9e6
Version: 2
Effective Time: 20181213
 
Young Dental Manufacturing I, LLC