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, Xylitol
Slideshow: 10 Things to Know About Antibiotic Resistance
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 LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-005-04
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
Kids Choice stannous fluoride gel, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-006-04
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
Kids Choice stannous fluoride gel, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-007-04
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
Kids Choice stannous fluoride gel, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-008-04
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
Kids Choice stannous fluoride gel, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-009-04
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
Kids Choice stannous fluoride gel, dentifrice
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC: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
#
Item Code
Package Description
1
NDC:63783-015-04
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
More than one in every five Americans has untreated cavities, a new government report shows.
"Untreated tooth decay is prevalent in the U.S." said report...
