Otc - Active Ingredient
Active ingredients
Sodium Fluoride (0.24%)
Smile Paint Kit
FDA Label NDC 87245-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jabber Jaw Kids Toothpaste Llc for the product Smile Paint (NDC 87245-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Anticavity
Indications & Usage
Uses ■ helps protect against cavities
Warnings
Warnings
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Questions or comments?
Visit www.smilepainttoothpaste.com
Package Labeling:
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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
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