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| Product NDC Code | 76357-419 | ||||
|---|---|---|---|---|---|
| Drug Name | Smartmouth mouthwash smartmouth mouth sore zinc activated formula |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 2108024 | ||||
| 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 Menthol 0.2% (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 & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. 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, Sorbitol, Poloxamer 407, Glycerin, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Peppermint Oil, Benzoic Acid, Aloe Extract, Sodium Chloride, 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 For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. For the temporary relief of pain associated with: Canker sores Minor dental procedures Minor irritation or injury of the mouth or gums Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Purpose
Information about the drug product’s indications for use.Purpose Oral Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula MENTHOL, UNSPECIFIED FORM SmartMouth Mouthwash Mouth Sore Solution 1 WATER Sodium Benzoate Sodium Chlorite Benzoic Acid WHITE SmartMouth Mouthwash Mouth Sore Solution 2 MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Water Glycerin Poloxamer 407 Propylene Glycol Aloe Poloxamer 124 Zinc Chloride Sodium Benzoic Acid Saccharin Sodium Sodium Chloride Benzyl Alcohol Sorbitol Peppermint 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 Bottle Label NEW & IMPROVED POUR MIXES TO ACTIVATE 2 Powerful Solutions BLOCKS ODORS FRESHENS BREATH smart mouth™ Mouth Sore Scientifically Proven Smart-Zinc™ Technology 24 HOUR BAD BREATH PREVENTION WITH A MORNING & EVENING RINSE Oral Pain Relief For CANKER SORES & CHEEK BITES GUM, BRACES & DENTURE IRRITATION COOL MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE PRINCIPAL DISPLAY PANEL - Kit 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
DISTRIBUTED BY: TRIUMPH PHARMACEUTICALS INC. ST. LOUIS, MISSOURI 63141
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product for more than 7 days unless directed by a dentist or healthcare provider
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. 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
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 see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not swallow do not exceed recommended dosage
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 Do not use this product for more than 7 days unless directed by a dentist or healthcare provider When using this product do not swallow do not exceed recommended dosage Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of reach of children. 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