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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, 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


GRAPE LABEL


BUBBLE GUM LABEL


LIMEAIDE LABEL


MINT LABEL


COTTON CANDY LABEL

CHERRY LABEL

KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (BUBBLE GUM) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-005-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCREME DE MENTHE (HINT OF MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-006-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLIME (LIMEAIDE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-007-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-008-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-009-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
KIDS CHOICE 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDY (COTTON CANDY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-015-04120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/1989
Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
NameAddressID/FEIBusiness Operations
Massco Dental A Division of Dunagin Pharmaceuticals008081858manufacture(63783-005, 63783-006, 63783-007, 63783-008, 63783-009, 63783-015)

Revised: 2/2020
Document Id: 2e9574c0-7052-4a22-98bd-e72b13bcecdc
Set id: cbf7907e-72c7-4328-8bd4-bf70daa35ef9
Version: 6
Effective Time: 20200217
 
Massco Dental A Division of Dunagin Pharmaceuticals