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| Product NDC Code | 10237-262 | ||||
|---|---|---|---|---|---|
| Drug Name | Therabreath overnight chamomile mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| Application Number | M022 | ||||
| Labeler Name | Church & Dwight Co., 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 Ingredients Sodium Fluoride 0.05% (0.02% wh fluoride ion)
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 18 years of age or older: Use once a day atter brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, 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.Use Aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Therabreath Overnight Chamomile Mint SODIUM FLUORIDE WATER GLYCERIN SODIUM BENZOATE SODIUM HYDROXIDE SODIUM CHLORITE CITRIC ACID MONOHYDRATE SUCRALOSE POLYOXYL 40 HYDROGENATED CASTOR OIL SODIUM FLUORIDE FLUORIDE ION
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 ANTICAVITY FLUORIDE RINSE STRENGTHENS TEETH TheraBreath ™ DENTIST FORMULATED OVERNIGHT ORAL RINSE FIGHTS BAD BREATH FOR 12 HOURS* HELPS PREVENT CAVITIES & REBUILD ENAMEL No Alcohol • No Dyes Non Burning IMPORTANT: Read directions for proper use. 16 fl. oz. 473 mL CHAMOMILE MINT 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
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 with another fluoride rinse on the same day.
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 the reach of children. If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not use if safety seal is broken or missing
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 Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away. Do not use with another fluoride rinse on the same day.
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