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| Product NDC Code | 0135-0451 | ||||
|---|---|---|---|---|---|
| Drug Name | Sensodyne pronamel intensive enamel repair extra fresh |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 240698 | ||||
| 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 Sodium fluoride 0.05% (0.02% 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 6 years of age and older: • use once a day after brushing your teeth with a toothpaste. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • do not swallow the rinse. • do not drink from the bottle. • do not rinse mouth with water. • do not eat or drink for 30 minutes after rinsing. • instruct children under 12 years of age in good rinsing habits (to minimize swallowing). • supervise children as necessary until capable of using without supervision. • children under 6 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Clean Mint) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate
Inactive ingredients (Extra Fresh) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1
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. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh sodium fluoride WATER SORBITOL SODIUM BENZOATE POLOXAMER 407 BENZYL ALCOHOL POLYSORBATE 20 PROPYLENE GLYCOL SACCHARIN SODIUM EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM EDETATE CALCIUM DISODIUM CETYLPYRIDINIUM CHLORIDE POTASSIUM SORBATE FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint sodium fluoride WATER SORBITOL SODIUM BENZOATE POLOXAMER 407 BENZYL ALCOHOL POLYSORBATE 20 PROPYLENE GLYCOL SACCHARIN SODIUM EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM EDETATE CALCIUM DISODIUM CETYLPYRIDINIUM CHLORIDE POTASSIUM SORBATE SODIUM 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 (Clean Mint) New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR CLEAN MINT Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204828 Back: 204832 Sensodyne Pro Inten Enamel Repair Clean Mint 500 mL
Principal Display Panel (Extra Fresh) New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR EXTRA FRESH Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204830 Back: 204831 Sensodyne Pro Inten Enamel Repair Extra Fresh 500 mL
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 • do not store above 25°C (77°F)
Other Information Re-mineralizing action for strong and protected teeth* Alcohol Free** SLS Free Paraben Free Dye Free ALWAYS FOLLOW THE LABEL Do not use if printed safety seal around cap is broken or missing. *when used as directed with a fluoride toothpaste **contains no ethanol Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Made in Taiwan
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 rinsing 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
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.Warning Keep Out of Reach of Children. If more than used for rinsing 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