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| Product NDC Code | 53238-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Periosciences hydrating ao pro |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | part355 | ||||
| Labeler Name | PERIOSCIENCES LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium monofluorophosphate 0.76%
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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Ask a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aqua (water), glycerin, hydrated silica, xylitol, sorbitol, propylene glycol, sodium methyl cocoyl taurate, propanediol, sodium bicarbonate, pvp, cocamidopropyl betaine, hydroxyapatite, ferulic acid, phloretin, sodium hyaluronate, echinacea purpurea (cone flower) extract, panthenol, menthol, sodium ascorbyl phosphate, zanthoxylum americanum (prickly ash) bark extract, ethyl lauroyl arginate hcl, cellulose gum, stevia rebaudiana bertoni, sodium citrate, potassium sorbate, mentha arvensis (wild mint) leaf oil, potassium chloride
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.Uses Aids in 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.PERIOSCIENCES HYDRATING AO Pro SODIUM MONOFLUOROPHOSPHATE WATER GLYCERIN HYDRATED SILICA XYLITOL SORBITOL PROPYLENE GLYCOL SODIUM METHYL COCOYL TAURATE PROPANEDIOL SODIUM BICARBONATE COCAMIDOPROPYL BETAINE TRIBASIC CALCIUM PHOSPHATE FERULIC ACID PHLORETIN HYALURONATE SODIUM PANTHENOL MENTHOL SODIUM ASCORBYL PHOSPHATE ETHYL LAUROYL ARGINATE HYDROCHLORIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM CITRATE POTASSIUM SORBATE POTASSIUM CHLORIDE SODIUM MONOFLUOROPHOSPHATE 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.PERIOSCIENCES HYDRATING AO ProToothpaste Antioxidant gel toothpaste with targeted moisturizers to revitalize oral tissues Net 3 fl oz / 90 ml REDEFINING ORAL CARE WITH ANTIOXIDANTS
PERIOSCIENCES HYDRATING AO ProToothpaste 90ml (53238-003-90) Inner Label Outer 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.PERIOSCIENCES HYDRATING AO ProToothpaste
Other information Not intended for ingestion. Upon application in the mouth, if you experience any irritation or unusual sensitivity, discontinue and consult your dental professional.
HYDRATING AO ProToothpaste AO Pro Toothpaste/Hydrating is a fluoride toothpaste that cleans teeth gently without abrasion and leaves a hydrated feeling. The multifunctional formula with PerioSciences signature antioxidants and a specific combination of minerals, botanicals and other moisturizers supports your saliva's natural defenses and is ideally suited for dry mouth conditions. Free of alcohol, parabens and sodium lauryl sufate. For best results, use with AO ProRinse/Hydrating and AO ProVantage Antioxidant Gel. Manufactured and distributed by: Periosciences LLC 11700 Preston Road #660 Dallas, TX 75230 www. PerioSciences.com - Made in USA
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 2 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call toll-free 1-800-915-8110
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 Keep out of reach of children under 2 years of age. If more than used for brushing 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