Jabber Jaw Smile Paint Sodium Fluoride Kit

Jabber Jaw Smile Paint Sodium Fluoride Kit
SPL v1
SPL
SPL Set ID a7463b5c-53b2-4353-a5ea-800fbd7bd17d
Route
DENTAL
Published
Effective Date 2026-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol, Unspecified Xylitol Carboxymethylcellulose Sodium Sodium Phosphate, Monobasic, Unspecified Form Titanium Dioxide Potassium Sorbate Saccharin Sodium Tricalcium Phosphate Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Active ingredients Sodium Fluoride  (0.24%)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses  ■ helps protect against cavities

Dosage and 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

Description

Active ingredients Sodium Fluoride  (0.24%)

Section 50565-1

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.

Section 51727-6

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

Section 53413-1

Questions or comments?

Visit www.smilepainttoothpaste.com

Section 55105-1

Purpose   Anticavity

Section 55106-9

Active ingredients

Sodium Fluoride  (0.24%)

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


Structured Label Content

Indications and Usage (34067-9)

Uses  ■ helps protect against cavities

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments?

Visit www.smilepainttoothpaste.com

Section 55105-1 (55105-1)

Purpose   Anticavity

Section 55106-9 (55106-9)

Active ingredients

Sodium Fluoride  (0.24%)

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


Advanced Ingredient Data


Raw Label Data

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