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Product NDC Code | 11822-5061 | ||||
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Drug Name | Rite aid gum and enamel repair |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 416784 | ||||
Application Number | M021 | ||||
Labeler Name | Rite Aid | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Stannous Fluoride 0.454% (0.14% w/v fluoride ion) ..... Anticavity, Antigingivitis
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.Aids in the prevention of cavities. Helps prevent gingivitis. Helps interfere with the harmful effects of plaque associated with gingivitis. Helps control plauqe bacteria that contribute to the development of gingivitis.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide
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.Adults and children 12 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. Do not swallow. Children under 12 years of age: ask a dentist.
Purpose
Information about the drug product’s indications for use.Products containing stannous fluoride may product surface staining of the teeth. Adequate tooth brushing may prevent these stains whcih are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to help prevent staining. See your dentist regularly.
Spl product data elements
Usually a list of ingredients in a drug product.Rite Aid Gum and Enamel Repair Stannous Fluoride WATER SODIUM LAURYL SULFATE SODIUM HYDROXIDE ZINC CITRATE SUCRALOSE XANTHAN GUM CARRAGEENAN TITANIUM DIOXIDE HYDRATED SILICA SACCHARIN SODIUM SORBITOL 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.5820061
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 chidlren under 12 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.Keep out of reach of children under 12 years of age. If more htan used for brushing is accidentally swallowd, 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