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| Product NDC Code | 82214-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Moon charcoal whitening anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M022 | ||||
| Labeler Name | Moon Oral Care, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Children of 6 years and younger: Use a pea sized amount with supervised brushing to minimize swallowing.
Purpose
Information about the drug product’s indications for use.Use aids in the prevention of dental cavities
Spl product data elements
Usually a list of ingredients in a drug product.Moon Charcoal Whitening Anticavity Sodium Fluoride SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE MICA SODIUM ACID PYROPHOSPHATE COCONUT OIL TEA TREE OIL CRANBERRY SEED OIL GREEN TEA LEAF ASIAN GINSENG STEVIA REBAUDIUNA LEAF SEA SALT SUCRALOSE SODIUM COCO-SULFATE SORBITOL SODIUM COCOYL GLUTAMATE SODIUM FLUORIDE FLUORIDE ION SODIUM POLYMETAPHOSPHATE ECHINACEA ANGUSTIFOLIA LEAF ACTIVATED CHARCOAL CHONDRUS CRISPUS CARRAGEENAN PEPPERMINT OIL MENTHA ARVENSIS LEAF OIL MYRCIARIA DUBIA FRUIT TITANIUM DIOXIDE GLYCERIN SODIUM GLUCONATE HYDRATED SILICA WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Tube
Outer
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warning Contains Sodium Fluoride. In case of intake of fluoride from other sources consult a dentist or doctor.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API