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| Product NDC Code | 54473-301 | ||||
|---|---|---|---|---|---|
| Drug Name | Whitening tooth polish |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | part355 | ||||
| Labeler Name | Melaleuca, Inc. | ||||
| 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 (0.243%)
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 of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 2 years of age: consult a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol
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.Use aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Whitening Tooth Polish Sodium Fluoride ALOE VERA LEAF ASCORBYL PALMITATE GREEN TEA LEAF MYRRH OIL GLYCERIN HYDRATED SILICA TEA TREE OIL PAPAIN POLOXAMER 407 ACESULFAME POTASSIUM SODIUM LAURYL SULFATE SODIUM BENZOATE SORBITOL POTASSIUM PYROPHOSPHATE SODIUM PYROPHOSPHATE TITANIUM DIOXIDE ALPHA-TOCOPHEROL ACETATE WATER XANTHAN GUM XYLITOL SODIUM FLUORIDE FLUORIDE ION Cool Mint
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.image of label
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. Warning: This product contains propolis, which can cause allergic reactions.
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.Warnings
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