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| Product NDC Code | 10237-264 | ||||
|---|---|---|---|---|---|
| Drug Name | Therabreath plus fresh breath |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| 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 0.24% (0.14% W/V 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 & Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)
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 Aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity Fluoride Dentifrice
Spl product data elements
Usually a list of ingredients in a drug product.TheraBreath Plus Fresh Breath Sodium fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN XYLITOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM PYROPHOSPHATE SODIUM PYROPHOSPHATE SODIUM BENZOATE ALOE VERA LEAF CITRIC ACID MONOHYDRATE SODIUM CHLORITE ZINC GLUCONATE AMMONIUM GLYCYRRHIZATE ASCORBIC ACID UBIDECARENONE MENTHA ARVENSIS LEAF OIL SPEARMINT OIL
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 - 113.5 g Tube Label ANTICAVITY TOOTHPASTE CLINICAL FORMULA TheraBreath ® PLUS MAXIMUM STRENGTH FRESH BREATH TOOTHPASTE FRESHENS BREATH FOR 24 HOURS* Fortified with Zinc, Xylitol and Aloe Nothing Works Faster and Lasts Longer to Prevent Bad Breath Dr. Harold Katz net wt. 4 oz. • 113.5 g PEPPERMINT Principal Display Panel - 113.5 g Tube 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
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 brushing is accidentally swallowed, get 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 If spilled on fabrics, wash out immediately. This product was sealed with protective packaging at the laboratory. If seal is missing, do not use.
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 reach of children under 6 years of age. If more than used for brushing 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