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| Product NDC Code | 0135-5024 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sensodyne sensitivity and gum whitening |
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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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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 (Sensitivity & Gum Whitening) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Inactive ingredients (Sensitivity & Gum Mint) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Inactive ingredients (Clean & Fresh) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, 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 control bleeding gums. 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 Sensitivity and Gum Mint stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM SODIUM LAURYL SULFATE TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION SENSODYNE Sensitivity and Gum Whitening stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM SODIUM LAURYL SULFATE TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM 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 (Whitening) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION WHITENING SENSITIVITY & GUM IMPROVES GUM HEALTH NET WT 2.3 OZ (65.2 g) 62000000207518 Sensodyne Sensitivity Gum Whitening 65g
Principal Display Panel (Mint) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION MINT SENSITIVITY & GUM IMPROVES GUM HEALTH NET WT 3.4 OZ (96.4 g) 62000000207515 Sensodyne Sensitivity Gum Mint 96g
Principal Display Panel (Clean & Fresh) #1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION CLEAN & FRESH SENSITIVITY & GUM IMPROVES GUM HEALTH NET WT 3.4 OZ (96.4 g) 62000000207513 Sensodyne Sensitivity Gum CleanFresh 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. do not store above 30°C (86°F)
Additional Information (Whitening) ALWAYS FOLLOW THE LABEL Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TARGETS AND HELPS REMOVE PLAQUE BACTERIA RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH Why use Sensodyne Sensitivity & Gum? Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste. *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†
Additional Information (Mint and Clean & Fresh) SENSODYNE SENSITIVITY & GUM Tooth sensitivity & gum problems? Many people with sensitive teeth also have gum problems. Tooth sensitivity can occur when exposed dentin comes into contact with cold, hot, sweet and sour. Early gum problems are caused by a build-up of plaque bacteria, which can lead to redness, swelling, and bleeding. SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TARGETS AND HELPS REMOVE PLAQUE BACTERIA RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS *with twice daily brushing Why use Sensodyne Sensitivity & Gum? Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste. 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 maybe 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 maybe 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