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| Product NDC Code | 0135-0700 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sensodyne pronamel active shield fresh mint |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 1086243 | ||||||
| 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 Potassium nitrate 5% Sodium fluoride 0.25% (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 water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, xanthan gum, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide
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 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purposes Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.SENSODYNE PRONAMEL Active Shield Fresh Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Fresh Mint SENSODYNE PRONAMEL Active Shield Cool Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Cool Mint
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 SENSODYNE PRONAMEL ACTIVE SHIELD TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION FRESH MINT Builds Enamel Resistance For Cavity & Erosion Protection NET WT 3.4 OZ (96.4 g) 62000000200006 – Front Carton Sensodyne Pronamel Active Shield FM 3.4oz_Carton
Principal Display Panel SENSODYNE PRONAMEL ACTIVE SHIELD TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION COOL MINT WHITENING Builds Enamel Resistance For Cavity & Erosion Protection NET WT 3.4 OZ (96.4 g) 620000000200004 – Front Carton Sensodyne Pronamel Active Shield CM 3.4oz_Carton
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.Additional information (Fresh Mint) SENSODYNE PRONAMEL ACTIVE SHIELD No 1 dentist recommended brand for enamel protection & strengthening. Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear. New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.** Acids from foods, drinks or sugars weaken the enamel surface Pronamel has a proven formula that actively reinforces weakened enamel Proven to actively reinforce weakened enamel Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with: 2X stronger resistance against dietary acids from Day 1* Helps shield the enamel against erosion and cavities Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh *vs your mouth’s natural defenses ** With continued twice daily brushing, a healthy diet and regular dental visits. #vs Pronamel Daily Protection ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Additional information (Cool Mint) S ENSODYNE PRONAMEL ACTIVE SHIELD No 1 dentist recommended brand for enamel protection & strengthening. Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear. New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.** Acids from foods, drinks or sugars weaken the enamel surface Pronamel has a proven formula that actively reinforces weakened enamel Proven to actively reinforce weakened enamel Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with: 2X stronger resistance against dietary acids from Day 1* Helps shield the enamel against erosion and cavities Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh Effectively and gently removes stains for whiter teeth *vs your mouth’s natural defenses ** With continued twice daily brushing, a healthy diet and regular dental visits. #vs Pronamel Daily Protection ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not store above 25°C (77°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.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