Doctors Choice

Generic Name: stanous fluoride
Dosage Form: gel, dentifrice

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.

ACTIVE INGREDIENT


Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, Natural Flavor, Xylitol

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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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:63783-011-04 120 g in 1 BOTTLE, DISPENSING
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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:63783-012-04 120 g in 1 BOTTLE, DISPENSING
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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:63783-013-04 120 g in 1 BOTTLE, DISPENSING
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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:63783-016-04 120 g in 1 BOTTLE, DISPENSING
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 Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
Name Address ID/FEI Operations
Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture
Revised: 02/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals



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