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| Product NDC Code | 0135-0601 | ||||
|---|---|---|---|---|---|
| Drug Name | Parodontax |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| 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 % (0.110 % 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 2 years of age and older: apply toothpaste onto a toothbrush. brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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.
Purpose
Information about the drug product’s indications for use.Purposes Anticavity Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.parodontax stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION parodontax stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) COCAMIDOPROPYL BETAINE SACCHARIN SODIUM STANNOUS FLUORIDE FLUORIDE ION parodontax stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 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 NDC 0135-0598-01 parodontax CLEAN MINT DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH Helps prevent bleeding gums NET WT 3.4 OZ (96.4 g) PLAQUE BUILDS UP GUMS SWELL AND BLEED PARODONTAX HELPS REMOVE PLAQUE Healthy gums don’t bleed If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed. parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 106342XA 106342XA_parodontax_clean mint_3.4 OZ.JPG
Principal Display Panel NDC 0135-0599-02 parodontax EXTRA FRESH DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH Helps prevent bleeding gums NET WT 3.4 OZ (96.4 g) PLAQUE BUILDS UP GUMS SWELL AND BLEED PARODONTAX HELPS REMOVE PLAQUE Healthy gums don’t bleed If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed. parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 106344XA 106344XA_Parodontax_Extra Fresh_3.4 OZ.JPG
Principal Display Panel NDC 0135-0601-01 parodontax WHITENING DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH Helps prevent bleeding gums NET WT 3.4 OZ (96.4 g) PLAQUE BUILDS UP GUMS SWELL AND BLEED PARODONTAX HELPS REMOVE PLAQUE Healthy gums don’t bleed If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed. parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 106345XA 106345XA_parodontax_whitening_3.4 OZ.JPG
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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another 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 specially formulated to help prevent staining. store below 25ºC (77ºF)
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? Call toll-free 1-855-328-5202
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 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 may be signs or symptoms of periodontitis, a serious form of gum disease.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, if irritation occurs discontinue 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 When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if 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 may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. 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