Otc - Active Ingredient
Active Ingredient Purpose
Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity
Moon Platinum Advanced Whitening Anticavity Paste
FDA Label NDC 82214-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Moon Oral Care Llc for the product Moon Platinum Advanced Whitening Anticavity (NDC 82214-001). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use Aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.
Warnings
Warning
Contains Sodium Fluoride. In case of intake of flouride from other sources consult a dentist or doctor.
Dosage & Administration
Directions
adults and children 2 years and older:
- brush teeth thoroughly after meals at least twice a day or use as directed by a dentist
- do not swallow
- to minimize swallowing, use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
- children under 2 years ask a dentist
Inactive Ingredient
Inactive ingredients
Glycerin, Water, Hydrated Silica, Xylitol, Flavor, hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Sodium Saccharin,
Package Label.Principal Display Panel
Moon Platinum
Advanced Whitening
Fluoride
Premium Freshening
Anticavity Toothpaste
Platinum Mint
119 g Net Wt. 4.2 OZ
Moon Plat Fluoride Paste (Moon Plat Fluoride Paste Box Usa 082421 01)
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