KIDS CHOICE

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: 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

KIDS CHOICE stannous fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG 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) FLUORIDE ION 0.12 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 Multilevel Packaging 1 NDC: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 unapproved drug other 01/01/1989 12/31/2023

KIDS CHOICE stannous fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG 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) FLUORIDE ION 0.12 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 Multilevel Packaging 1 NDC: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 unapproved drug other 01/01/1989 12/31/2023

KIDS CHOICE stannous fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG 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) FLUORIDE ION 0.12 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 Multilevel Packaging 1 NDC: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 unapproved drug other 01/01/1989 12/31/2023

KIDS CHOICE stannous fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG 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) FLUORIDE ION 0.12 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 Multilevel Packaging 1 NDC: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 unapproved drug other 01/01/1989 12/31/2023

KIDS CHOICE stannous fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG 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) FLUORIDE ION 0.12 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 Multilevel Packaging 1 NDC: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 unapproved drug other 01/01/1989 12/31/2023

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 (63783-005), manufacture (63783-006), manufacture (63783-007), manufacture (63783-008), manufacture (63783-009)

Revised: 12/2022 Massco Dental A Division of Dunagin Pharmaceuticals