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| Product NDC Code | 11822-5005 | ||||
|---|---|---|---|---|---|
| Drug Name | Complete protection tp |
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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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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)
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.adults and children 12 years of age adn older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. * children under 12 years of age: consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.glycerin, water, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, cocamidopropyl betaine, 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.aids in the prevention of dental cavities * helps interfere with the harmful effects of plaque associated with gingivitis * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Purpose
Information about the drug product’s indications for use.Anticavity, Antigingivitis, Antihypersensitivity
Spl product data elements
Usually a list of ingredients in a drug product.Complete Protection TP Stannous fluoride SODIUM TRIPOLYPHOSPHATE ANHYDROUS SACCHARIN SODIUM SACCHARIN STANNOUS FLUORIDE FLUORIDE ION HYDRATED SILICA COCAMIDOPROPYL BETAINE WATER GLYCERIN TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE White to off white
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.Carton R1
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 from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. * this product is specifically formulated to help prevent staining. * store below 30*C (86*F)
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.When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if: * the problems persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist * pain/sensitivity still persists after 4 weeks of use * gingivitis, bleeding, or redness persists for more than 2 weeks * you have painful or swollen gums, pus from teh gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children. If more than used from 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