SMILE PAINT- sodium fluoride kit

Smile Paint by

Drug Labeling and Warnings

Smile Paint by is a Otc medication manufactured, distributed, or labeled by JABBER JAW KIDS TOOTHPASTE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Sodium Fluoride  (0.24%)

Purpose  Anticavity

INDICATIONS & USAGE

Uses ■ helps protect against cavities

WARNINGS

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions ■twist off cap and remove foil ■do not swallow ■supervise children

as necessary until capable of using without supervision.

• adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
• children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)
• children under 2 years: ask a dentist or physician

INACTIVE INGREDIENT

Inactive ingredients 

Water, Sorbitol, Hydrated Silica, Glycerin,
Polyethylene glycol, Xylitol, Sodium
Carboxymethylcellulose, Monosodium
phosphate, Titanium dioxide, Flavor, Potassium
sorbate, Sodium saccharin, Tricalcium
phosphate, Citric acid

QUESTIONS

Questions or comments?

Visit www.smilepainttoothpaste.com

Package Labeling:

-------------------------------------------------------------------

The Play-Based

Toothpaste

Smile Paint®

Vanilla Cupcake

Fluoridated,

Natural Flavor & Color

NET WT 4 OZ (113g)

DISTRIBUTED BY

JABBER JAW KIDS TOOTHPASTE, LLC

TAMPA, FL 33611-2703

www.smilepainttoothpaste.com

Kit

Tube

res

INGREDIENTS AND APPEARANCE

SMILE PAINT 
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87245-001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87245-001-01	1 in 1 KIT	12/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	113 g

Part 1 of 1

VANILLA CUPCAKE 
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC: 87245-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87245-100-04	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	12/01/2025

Labeler - JABBER JAW KIDS TOOTHPASTE LLC (102173014)