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| Product NDC Code | 76357-285 | ||||
|---|---|---|---|---|---|
| Drug Name | Smartmouth mouthwash clinical dds formula |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | part356 | ||||
| Labeler Name | Triumph Pharmaceuticals 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 0.05% (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 Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (5 pumps from each bottle) 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.
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, 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 Mouthwash Clinical DDS Formula Cetylpyridinium Chloride SmartMouth Clinical DDS Solution 1 Water Sodium Benzoate Sodium Chlorite Benzoic Acid Clear Water SmartMouth Clinical DDS Solution 2 Mint Cetylpyridinium Chloride Cetylpyridinium Chloride Cetylpyridinium Water Glycerin Poloxamer 407 Propylene Glycol Poloxamer 124 Zinc Chloride Sodium Benzoate Benzoic Acid Saccharin Sodium Sodium Chloride Benzyl Alcohol D&C Yellow No. 10 FD&C Blue No. 1 mint vanilla
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 Cello Pack H 2 S ELIMINATOR ∞ & Zn +2 ACTIVATOR smart mouth™ OTC Activates Zinc Ions Blocks Sulfur Gas Clinical DDS™ ACTIVATED ORAL RINSE™ PRESCRIPTION STRENGTH + Gingivitis & Bleeding Gums Protection 24HR BAD BREATH PREVENTION* AM RINSE = ALL DAY CLEAN BREATH PM RINSE = ELIMINATES MORNING BREATH GUARANTEED † PATENTED FORMULA • DENTIST DEVELOPED CLEAN MINT • NO AFTERTASTE ALCOHOL FREE • SAFE FOR DIABETICS TOTAL NET WT. 32 FL. OZ. (960 mL) Principal Display Panel - Kit Cello Pack
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
SMARTMOUTH™ & SMART MOUTH™ ARE TRADEMARKS OF & DISTRIBUTED BY: TRIUMPH PHARMACEUTICALS INC. • ST. LOUIS, MISSOURI 63141
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 or comments 1-800-492-7040
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 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