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| Product NDC Code | 57660-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Plaque refresh remineralizing rinse fresh mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 313029 | ||||
| Application Number | M021 | ||||
| Labeler Name | TJA Health 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 0.02% (0.01% w/v Fluoride Ion) Purpose 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 12 years of age or older: - use twice daily after brushing your teeth - vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out - do not swallow the rinse - do not eat or drink for 30 minutes after rinsing - supervise children as necessary - Children under 12 year of age: consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, sorbitol, vegetable glycerin, xylitol, poloxamer-407, polysorbate-20, sodium bicarbonate (baking soda), aloe barbadensis leaf juice extract, persea gratissima (avocado) oil, tocopherol acetate (natural vitamin E), mentha viridis (spearmint) leaf oil, mentha piperita (peppermint) oil, melaleuca alternifolia (tea tree) leaf oil, citrus paradisi (grapefruit) seed oil, eucalyptus globulus leaf oil, menthol, thymol, gaultheria procumbens (wintergreen) leaf oil, bixa orellana (annatto) seed extract, PVP, calcium lactate, tetrasodium pyrophosphate, sodium hexametaphosphate, blue no.1, zinc citrate, sodium benzoate, sodium gluconate, phosphoric acid, cellulose gum, disodium EDTA.
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.Plaque Refresh Remineralizing Rinse Fresh Mint SODIUM FLUORIDE ALOE VERA LEAF WATER SORBITOL GLYCERIN XYLITOL POLYSORBATE 20 SODIUM BICARBONATE AVOCADO OIL .ALPHA.-TOCOPHEROL ACETATE SPEARMINT OIL PEPPERMINT OIL TEA TREE OIL GRAPEFRUIT SEED OIL EUCALYPTUS OIL MENTHOL THYMOL METHYL SALICYLATE BIXA ORELLANA SEED POVIDONE, UNSPECIFIED CALCIUM LACTATE SODIUM PYROPHOSPHATE HEXASODIUM HEXAMETAPHOSPHATE SODIUM POLYMETAPHOSPHATE FD&C BLUE NO. 1 ZINC CITRATE SODIUM BENZOATE SODIUM GLUCONATE PHOSPHORIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM ANHYDROUS SODIUM FLUORIDE FLUORIDE ION POLOXAMER 407
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.Package Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information - store at room temperature - cold weather may temporarily cloud this product
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. If more than used for rinsing 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.Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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