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| Product NDC Code | 0135-0652 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Parodontax active gum health daily mouthwash breath freshener |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| 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 (500 mL) ■ 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
Directions (1000 mL) ■ adults and children 6 years of age and older: vigorously swish 20 milliliters (4 teaspoonfuls) of 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 water, glycerin, poloxamer 407, flavor, benzoic acid, sodium benzoate, sucralose, zinc lactate, sodium saccharin, green 3, yellow 6, cinnamal
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.Purposes Antigingivitis, Antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Parodontax Active Gum Health Daily Mouthwash Breath Freshener Cetylpyridinium chloride CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM GLYCERIN POLOXAMER 407 BENZOIC ACID SODIUM BENZOATE SUCRALOSE ZINC LACTATE SACCHARIN SODIUM FD&C GREEN NO. 3 FD&C YELLOW NO. 6 CINNAMALDEHYDE
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 NEW HALEON parodontax CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE DAILY MOUTHWASH HELPS PREVENT BLEEDING GUMS & BAD BREATH BACTERIA BREATH CLEANSE TECHNOLOGY BREATH FRESHENER KILLS 99.9% PLAQUE BACTERIA* ALCOHOL FREE NET WT 16.9 FL OZ (500 mL) 206166 L0021380FA Parodontax Active Gum Health MW 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.Generic Section ALWAYS FOLLOW THE LABEL Do not use if printed safety seal around cap is broken or missing. Pat. Info www.productpats.com Distributed by: Haleon, Warren, NJ 07059 Trademarks owned or licensed by Haleon. ©2023 Haleon or licensor. *Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test BOTTLE RECYCLE CAP CHECK LOCALLY †Recycling facilities for this product may not exist in your area 206167 L0021380BA
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 product is not intended to replace brushing or flossing ■ may cause staining ■ do not store above 25°C (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? 1-866-844-2797
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 ■ 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