Doctors Choice

Dosage Form: gel, dentifrice

ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, Natural Flavor, Xylitol

USE

Aids in the prevention of dental decay.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.

Children 6-11 Years:  See directions above.  Adult supervision required.

Children Under 6: Consult a Dentist or Physician.

OTHER INFORMATION

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

QUESTIONS ? COMMENTS ?

Questions?? Comments??

Call 1-479-787-5168 M-F 9am to 5pm CST

Warnings

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

PACKAGE LABEL

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel

Manufactured by Massco Dental

Doctors Choice  stanous fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-011 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .45103 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor SPEARMINT (MINT FLAVOR) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-011-04 120 g In 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Doctors Choice  stannous fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-012 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor CINNAMON (CINNAMON FLAVOR) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-012-04 120 g In 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Doctors Choice  stannous fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-013 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor GRAPE (CARIBBEAN ICE FLAVOR) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-013-04 120 g In 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Doctors Choice  stannous fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-016 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-016-04 120 g In 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals

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