KIDS CHOICE  - stannous fluoride gel, dentifrice 
Massco Dental A Division of Dunacin Pharmaceuticals

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ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose

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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-005 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 BUBBLE GUM (BUBBLE GUM) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-005-04 120 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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-006 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 CREME DE MENTHE (HINT OF MINT) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-006-04 120 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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-007 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 LIME (LIMEAIDE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-007-04 120 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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-008 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 (GRAPE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-008-04 120 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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-009 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 CHERRY (CHERRY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-009-04 120 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

KIDS CHOICE  stannous fluoride   gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-015 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 COTTON CANDY (COTTON CANDY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-015-04 120 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: 04/2011Massco Dental A Division of Dunacin Pharmaceuticals