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Product NDC Code | 84181-735 | ||||
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Drug Name | Dr. jen superpaste nano-hydroxyapatite |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 245598 | ||||
Application Number | M021 | ||||
Labeler Name | Dr Jen Natural, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS Active Ingredient Sodium Fluoride 0.22%
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: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Glycerin, Hydrated Silica, Xylitol, Nano-Hydroxyapatite, Calcium Carbonate, Sodium Methyl Cocoyl Taurate, Sodium Carboxymethyl- cellulose, Natural Strawberry Flavor, Stevia Rebaudiana Leaf Extract, Citric Acid, Illicium Verum (Anise) Fruit Extract, Carica Papaya Extract, Prunus Serotina (Black Cherry) Bark Extract, Glycyrrhiza Uralensis (Chinese Licorice) 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.Use: Aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose: Sodium Fluoride - Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN HYDRATED SILICA XYLITOL TRIBASIC CALCIUM PHOSPHATE CALCIUM CARBONATE SODIUM METHYL COCOYL TAURATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED STEVIA REBAUDIUNA LEAF CITRIC ACID MONOHYDRATE STAR ANISE FRUIT CARICA PAPAYA LEAF PRUNUS SEROTINA BARK GLYCYRRHIZA URALENSIS ROOT
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.Dr. Jen SuperPaste Product Package Labeling Dr. Jen Super Paste TRIPLE CAVITY PROTECTION 10% NANO-HYDROXYAPATITE, FLUORIDE & XYLITOL TOOTHPASTE Strawberry 3.4 FL. OZ. | 100 ML DrJenNatural.com Dr. Jen St. Paul, MN 55118 res 735 Box 735 Tube
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.
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: 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