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| Product NDC Code | 0135-0622 | ||||
|---|---|---|---|---|---|
| Drug Name | Sensodyne rapid relief |
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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 (Extra Fresh) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Inactive ingredients (Mint) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine
Inactive Ingredients (Whitening) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine
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 Rapid Relief stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION Extra Fresh SENSODYNE Rapid Relief stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE SACCHARIN SODIUM COCAMIDOPROPYL BETAINE STANNOUS FLUORIDE FLUORIDE ION SENSODYNE Rapid Relief stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE SACCHARIN SODIUM COCAMIDOPROPYL BETAINE 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 #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION EXTRA FRESH RAPID RELIEF & LONG LASTING PROTECTION** NET WT 3.4 OZ (96.4 g) 62000000207034 Sensodyne Rapid Relief Extra Fresh 96g
Principal Display Panel #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION MINT RAPID RELIEF & LONG LASTING PROTECTION** NET WT 3.4 OZ (96.4 g) 62000000207014 Sensodyne Rapid Relief Mint 96g
Principal Display Panel NDC 0135-0632-01 #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION WHITENING RAPID RELIEF & LONG LASTING PROTECTION** NET WT 3.4 OZ (96.4 g) 62000000057071 Carton Sensodyne Rapid Relief Whitening 3.4 oz (96.4 g)
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 do not store above 30°C (86°F)
Additional Information ALWAYS FOLLOW THE LABEL SENSODYNE RAPID RELIEF What is tooth sensitivity? Sensitivity occurs when the dentin underneath tooth enamel becomes exposed. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve causing a short, sharp pain. CAUSE OF SENSITIVITY PAIN TINY HOLES IN DENTIN FAST ACTING FORMULA QUICKLY CREATES A BARRIER FAST RELIEF FROM PAIN* Fast RELIEF * and Long lasting Protection** Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop the pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining. *significant pain relief in 3 days **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
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