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| Product NDC Code | 10237-258 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Therabreath healthy gums |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | RINSE | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Church & Dwight Co., Inc. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Cetylpyridinium Chloride 0.05%
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 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. Children 6 years to under 12 years Supervise use. Children under 6 years Do not use.
| Adults and Children 12 years 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. |
| Children 6 years to under 12 years | Supervise use. |
| Children under 6 years | Do not use. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin, Poloxamer 407, Flavor, Sucralose
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 gingivitis, an early form of gum disease and bleeding gums Helps control plaque that leads to gingivitis and 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.TheraBreath Healthy Gums CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM WATER GLYCERIN POLOXAMER 407 SUCRALOSE
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 - 473 mL Bottle Label ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE SAVE! VALUE SIZE TheraBreath ™ DENTIST FORMULATED HEALTHY GUMS ORAL RINSE HELPS FIGHT GINGIVITIS FOR 24 HOURS* HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE Reduces Occurrence of Bleeding Gums • Freshens Breath No Alcohol • No Dyes • Non Burning CLEAN MINT 33.8 fl. oz. 1 liter PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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.Drug Facts
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.
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 teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Storage and handling
Information about safe storage and handling of the drug product.Other information This rinse is not intended to replace brushing or flossing.
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 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 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