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| Product NDC Code | 0135-0573 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sensodyne complete protection |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 416784 | ||||||
| Application Number | M022 | ||||||
| Labeler Name | Haleon US Holdings LLC | ||||||
| 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.Active ingredient Stannous fluoride 0.454% (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.Directions adults and children 12 years of age and 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.Inactive ingredients (Mint) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine
Inactive ingredients (Extra Fresh) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, 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.Uses aids in the prevention of dental cavities. helps prevent gingivitis, an early form of gum disease. helps interfere with 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.Purposes Anticavity, Antigingivitis, Antihypersensitivity
Spl product data elements
Usually a list of ingredients in a drug product.Sensodyne Complete Protection stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE POLYACRYLIC ACID (250000 MW) SACCHARIN SODIUM COCAMIDOPROPYL BETAINE STANNOUS FLUORIDE FLUORIDE ION Sensodyne Complete Protection Extra Fresh stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE POLYACRYLIC ACID (250000 MW) COCAMIDOPROPYL BETAINE SACCHARIN SODIUM 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.Principal Display Panel (Mint) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PREVENTION NET WT 3.4 OZ (96.4 g) MINT COMPLETE PROTECTION SENSITIVITY ENAMEL CLEAN GUMS FRESH PLAQUE WHITENING 62000000207019 Sensodyne Mint Complete Protection 96g
Principal Display Panel (Extra Fresh) #1 DENTIST RECOMMENDED BRAND SENSODYNE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PREVENTION NET WT 3.4 OZ (96.4 g) EXTRA FRESH COMPLETE PROTECTION SENSITIVITY ENAMEL CLEAN GUMS FRESH PLAQUE ENAMEL WHITENING 62000000207024 Sensodyne Extra Fresh Complete Protection 96g
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.Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing 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)
Additional Information SENSODYNE COMPLETE PROTECTION What is tooth sensitivity? Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve inside the tooth causing a short, sharp pain. FRESH FEELING PROTECTS ENAMEL HELPS WHITEN ENAMEL PROTECTS AGAINST PLAQUE BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN* CLEAN FEELING HELPS PREVENT GINGIVITIS *with twice daily brushing Why use Sensodyne Complete Protection toothpaste? This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste. ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Distributed by: Haleon, Warren, NJ 07059 Pat. Info www.productpats.com † Recycling facilities for this product may not exist in your area CARTON RECYCLE TUBE RECYCLE CAP CHECK LOCALLY
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 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? 1-866-844-2797
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: the problem 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 the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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: the problem 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 the gum line, loose teeth, or increasing spacing between the 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 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