Otc - Active Ingredient
Active Ingredient: Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity
Moon Charcoal Whitening Anticavity Paste
FDA Label NDC 82214-003
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 Charcoal Whitening Anticavity (NDC 82214-003). 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 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 with supervised brushing to minimize swallowing.
Warnings
Warning
Contains Sodium Fluoride. In case of intake of fluoride from other sources consult a dentist or doctor.
Dosage & Administration
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
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, Hydrated Silica, Sorbitol, Water/Aqua/Eau, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Hexametaphosphate, Disodium Pyrophosphate, Stevia Rebaudiana Leaf Extract, Cocos Nucifera (Coconut) Oil, Mentha Piperita (Peppermint) Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Sea Salt, Echinacea Angustifolia Leaf Extract, Camellia Sinensis (Black and Green Teas) Leaf Extract, Panax Ginseng Root Extract, Mrciaria Dubia (Camu Camu) Fruit Extract, Carbon (Activated Charcoal), Sodium Benzoate, Titanium Dioxide, Chondrus Crispus Extract, Sodium Gluconate, Xanthan Gum, Sucralose, Citric Acid, Mica
Package Label.Principal Display Panel
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