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| Product NDC Code | 0135-0548 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sensodyne repair and protect |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| 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, silica, cocamidopropyl betaine, sodium saccharin
Inactive ingredients (Extra Fresh) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, sodium saccharin, cocamidopropyl betaine
Inactive ingredients (Whitening) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, 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. 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, Antihypersensitivity
Spl product data elements
Usually a list of ingredients in a drug product.SENSODYNE Repair and Protect stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION SENSODYNE Repair and Protect Extra Fresh stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE SACCHARIN SODIUM COCAMIDOPROPYL BETAINE STANNOUS FLUORIDE FLUORIDE ION SENSODYNE Repair and Protect Whitening stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE 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 AND CAVITY PREVENTION MINT REPAIR & PROTECT DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207021 Sensodyne Repair and Protect Mint 96g
Principal Display Panel (Extra Fresh) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION EXTRA FRESH REPAIR & PROTECT DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207114 Sensodyne Repair and Protect Extra Fresh 96g
Principal Display Panel (Whitening) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION WHITENING REPAIR & PROTECTED DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207026 Sensodyne Repair and Protect Whitening 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 product 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 above 30°C (86°F)
Other Information SENSODYNE REPAIR & PROTECT DEEP REPAIR Sensodyne Repair & Protect has a clinically proven ingredient. With twice daily brushing it helps to repair deep inside the tubules and relieves sensitivity to help you enjoy life without worrying about the pain of sensitive teeth. EXPOSED DENTIN; CAUSE OF SENSITIVE TEETH TINY HOLES GETS DEEP INSIDE THESE HOLES TO HELP REPAIR THESE HOLES WHICH HELPS PROTECT FROM PAIN* Daily use fluoride toothpaste to provide long lasting sensitivity relief, whilst also keeping your teeth and gums healthy. * *with twice daily brushing 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.
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. 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