FLUORISHIELD

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.

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
(click image for full-size original)

FLUORISHIELD
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8011
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 11 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8011-01 114 g in 1 TUBE None
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 Operations
Medical Products Laboratories, Inc. 002290302 manufacture (0273-8011)

Revised: 12/2018 Young Dental Manufacturing I, LLC

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