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| Product NDC Code | 76357-509 | ||||
|---|---|---|---|---|---|
| Drug Name | Smartmouth smartmouth gum health zinc activated formula |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1251617 | ||||
| Application Number | M022 | ||||
| Labeler Name | Triumph Pharmaceuticals, Inc. | ||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Cetylpyridinium Chloride 0.05% (when mixed as directed)
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 Use after your normal brushing and flossing routine Adults and children 12 years of age & older: vigorously swish 20 mL of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Do not swallow. Children 6 years to under 12 years of age: supervise use. Children under 6 years of age: do not use unless directed by a healthcare professional.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Aloe Vera, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Sodium Chloride, Benzyl Alcohol, D&C Yellow No. 10, FD&C Blue No. 1
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 and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.
Purpose
Information about the drug product’s indications for use.Purpose Anti-gingivitis/Anti-plaque
Spl product data elements
Usually a list of ingredients in a drug product.SmartMouth SmartMouth Gum Health Zinc Activated Formula Cetylpyridinium Chloride SmartMouth Gum Health Solution 1 Water Sodium Benzoate Sodium Chlorite Benzoic Acid SmartMouth Gum Health Solution 2 Cetylpyridinium Chloride Cetylpyridinium Chloride Cetylpyridinium Water Glycerin Poloxamer 407 Propylene Glycol ALOE POLOXAMER 124 Zinc Chloride SODIUM Benzoic Acid SACCHARIN SODIUM Sodium Chloride Benzyl Alcohol Mild Mint
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 - Kit Label MIXES TO ACTIVATE 2 Powerful Solutions smart mouth™ Gum Health Zinc Activated Breath Rinse™ 24 HOUR BAD BREATH PREVENTION WITH A MORNING & EVENING RINSE Advanced Germ Killing + BLEEDING GUMS PROTECTION SOOTHES WITH NATURAL ALOE MILD MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE PRINCIPAL DISPLAY PANEL - Kit 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
DISTRIBUTED BY: TRIUMPH PHARMACEUTICALS INC. ST. LOUIS, MISSOURI 63141
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a dentist if symptoms persist or condition worsens after regular use.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-492-7040
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 Ask a dentist if symptoms persist or condition worsens after regular use. 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