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| Product NDC Code | 11822-6034 | ||||
|---|---|---|---|---|---|
| Drug Name | Rite aid pro defense whitening |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416784 | ||||
| Application Number | part356 | ||||
| Labeler Name | Rite Aid | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous fluoride 0.454% (w/w)
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, and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established 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 Glycerin, Water, Hydrated Silica, Pentasodium Triphosphate, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin
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 the prevention of dental cavities helps control bleeding gums helps interfere with harmful effects of plaque associated with gingivitis
Purpose
Information about the drug product’s indications for use.Purpose Anticavity / Anti-gingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Rite Aid Pro Defense Whitening Stannous fluoride WATER SACCHARIN SODIUM TITANIUM DIOXIDE SODIUM LAURYL SULFATE GLYCERIN HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM TRIPOLYPHOSPHATE ANHYDROUS CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM STANNOUS FLUORIDE 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.RITE AID® PHARMACY oral care pro defense daily fluoride anticavity & anti-gingivitis toothpaste whitening NET WT 3.4 OZ (96.4 g) RA PRO DEFENSE 2821284R1
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
DISTRIBUTED BY: RITE AID 30 HUNTER LANE CAMP HILL, PA 17011
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if: gingivitis, bleeding or redness persists for more than 2 weeks if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease.
Storage and handling
Information about safe storage and handling of the drug product.Other information products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist. This product is specifically formulated to help prevent staining store below 77°F (25°C) Keep tube capped when not in use.
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 Stop use and ask a dentist if: gingivitis, bleeding or redness persists for more than 2 weeks if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease. 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.
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