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| Product NDC Code | 0135-0651 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Parodontax active gum health mint |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | MOUTHWASH | ||||||
| RxCUI drug identifier | 1100924 | ||||||
| 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 Cetylpyridinium chloride 0.07% w/w
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: measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle. • children 6 years to under 12 years of age: supervise use • children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Mint) Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1
Inactive Ingredients (Clear Mint) Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid
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 helps prevent and reduce plaque that leads to • gingivitis, an early form of gum disease • bleeding gums
Purpose
Information about the drug product’s indications for use.Purpose Antigingivitis, Antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Parodontax Active Gum Health Mint cetylpyridinium chloride CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM WATER GLYCERIN POLOXAMER 188 SACCHARIN SODIUM PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE 2,3'-IMINODI-BENZOIC ACID FD&C BLUE NO. 1 Parodontax Active Gum Health Clear Mint cetylpyridinium chloride CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM WATER GLYCERIN POLOXAMER 188 SACCHARIN SODIUM PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE BENZOIC ACID
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 0135-0651-02 NEW parodontax CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE ACTIVE GUM HEALTH DAILY MOUTHWASH TARGETS BACTERIA* & FORMS AN ANTIBACTERIAL SHIELD MINT KILLS 99.9% PLAQUE BACTERIA* 16.9 FL OZ (500 mL) L0020006FA: Front Label L0020006BA: Back Label parodontax active gum health mouthwash mint
Principal Display Panel NDC 0135-0650-01 NEW parodontax CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE ACTIVE GUM HEALTH DAILY MOUTHWASH TARGETS BACTERIA* & FORMS AN ANTIBACTERIAL SHIELD CLEAR MINT DYE FREE ALCOHOL FREE 16.9 FL OZ (500 mL) L0020007FA: Front Label L0020007BA: Back Label parodontax active gum health mouthwash clear mint
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 *Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test Do not use if the printed seal on the cap is broken or missing. ALWAYS FOLLOW THE LABEL
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 rinsing 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 • this rinse is not intended to replace brushing or flossing • may cause staining • Do not store above 25°C or 77°F
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? 1-855-328-5202
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 • irritation occurs • 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.
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 • irritation occurs • 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 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