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| Product NDC Code | 82214-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Moon whitening gel anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| 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% (0.14% w/v active 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.Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract
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 Whitening Gel Anticavity Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION MAGNESIUM CHLORIDE SODIUM POLYMETAPHOSPHATE CITRIC ACID MONOHYDRATE SODIUM ACID PYROPHOSPHATE TITANIUM DIOXIDE MYRCIARIA DUBIA FRUIT WATER SODIUM BENZOATE MICA SODIUM GLUCONATE SORBITOL SODIUM COCO-SULFATE MENTHA ARVENSIS LEAF OIL SODIUM SULFATE SODIUM COCOYL GLUTAMATE SUCRALOSE COCONUT OIL SEA SALT PEPPERMINT OIL ALCOHOL GREEN TEA LEAF STEVIA REBAUDIUNA LEAF CARVONE, (+/-)- METHYL SALICYLATE ECHINACEA ANGUSTIFOLIA LEAF ASIAN GINSENG HYDRATED SILICA GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARRAGEENAN VANILLIN CRANBERRY SEED OIL PROPANEDIOL
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 brushin is accidentally swallowed, get medical help or contact a Poison Control Center right away. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.
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.Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. 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