Smart Way Mint Cavity Protection Paste, Dentifrice
FDA Label NDC 59450-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Smart Way Mint Cavity Protection (NDC 59450-010). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Mono-fluorophosphate 0.76 %
(0.13 % w/v Fluoride ion)
Purpose
Anticavity
Uses
helps protect against cavities.
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of 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.
Directions
• 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.
• do not swallow.
• children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Sorbitol, Hydrated Silica, Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate
Questions Or Comments?
Call toll free 1-800-632-6900
Packaging
Smart Way Mint Anti-cavity (59450010 1)
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