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| Product NDC Code | 54473-294 | ||||
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| Drug Name | Breathaway mouth rinse fresh mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 1100924, 1100928 |
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| Application Number | part356 | ||||
| Labeler Name | Melaleuca, Inc. | ||||
| 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%
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 of age and older: vigorously swish 20 mL (4 teaspoonfuls) 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 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, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil
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 helps prevent plaque that leads to gingivitis
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.BreathAway Mouth Rinse Fresh Mint Cetylpyridinium Chloride ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ETHYL MENTHANE CARBOXAMIDE GLYCERIN MYRRH OIL POLOXAMER 407 POLYOXYL 40 HYDROGENATED CASTOR OIL POLYSORBATE 20 POTASSIUM SORBATE SODIUM BENZOATE SODIUM HYDROXIDE SORBITOL TEA TREE OIL WATER XYLITOL ZINC CITRATE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM
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.image of label
image of 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.
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 symptoms persist or condition worsens after regular use.
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