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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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


DOCTOR CHOICE CINNAMON LABEL


DOCTOR CHOICE MINT LABEL


DOCTOR CHOICE NATURAL LABEL

DOCTOR CHOICE CARRIBEAN LABEL


DOCTORS CHOICE 
stanous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.45103 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINT (MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63783-011-04120 g in 1 BOTTLE, DISPENSINGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

DOCTORS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.4510 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (CINNAMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63783-012-04120 g in 1 BOTTLE, DISPENSINGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

DOCTORS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.4510 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (CARIBBEAN ICE FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63783-013-04120 g in 1 BOTTLE, DISPENSINGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

DOCTORS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.4510 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63783-016-04120 g in 1 BOTTLE, DISPENSINGNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)
Establishment
NameAddressID/FEIOperations
Massco Dental A Division of Dunacin Pharmaceuticals008081858manufacture

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