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| Product NDC Code | 82214-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Moon platinum advanced 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 Purpose 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 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, Water, Hydrated Silica, Xylitol, Flavor, hydroxyapatite, Synthetic Fluorophlogopite, Cellulose Gum, Kaolin, Sodium Lauroyl Sarcosinate, Carrageenan, Sodium Saccharin,
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 for 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 Platinum Advanced Whitening Anticavity Sodium Fluoride TEA TREE OIL PEPPERMINT OIL WATER CARRAGEENAN TRIBASIC CALCIUM PHOSPHATE MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XYLITOL TITANIUM DIOXIDE MENTHOL MICA GLYCERIN HYDRATED SILICA SLOE KAOLIN SODIUM LAUROYL SARCOSINATE MYRCIARIA DUBIA FRUIT ASIAN GINSENG SACCHARIN SODIUM COCONUT OIL CRANBERRY SEED OIL GREEN TEA LEAF FERRIC OXIDE RED SEA SALT ECHINACEA ANGUSTIFOLIA LEAF SODIUM FLUORIDE FLUORIDE ION
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.Moon Platinum Advanced Whitening Fluoride Premium Freshening Anticavity Toothpaste Platinum Mint 119 g Net Wt. 4.2 OZ moon Plat Fluoride Paste
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 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 flouride 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