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Therabreath fresh breath anticavity mild mint - Medication Information

Product NDC Code 10237-263
Drug Name

Therabreath fresh breath anticavity mild mint

Type Brand
Active Ingredients
Sodium fluoride .24 g/100g
Route ORAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 416783
Application Number M021
Labeler Name Church & Dwight Co., Inc.
Packages
Package NDC Code Description
10237-263-04 1 tube in 1 carton (10237-263-04) / 113.5 g in 1 tube
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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 Do not swallow. Supervise children as necessary until capable of using without supervision. Adults and children 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Sorbitol, Water, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

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 decay.

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 Fresh Breath Anticavity Mild Mint Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN XYLITOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM PYROPHOSPHATE SODIUM PYROPHOSPHATE AMMONIUM GLYCYRRHIZATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE SODIUM CHLORITE ALOE VERA LEAF ASCORBIC ACID

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 Carton DENTIST FORMULATED FIGHTS CAVITIES FIGHTS BAD BREATH FOR 12H* ANTICAVITY FLUORIDE TOOTHPASTE TheraBreath ™ DENTIST FORMULATED FRESH BREATH TOOTHPASTE FIGHTS CAVITIES FIGHTS BAD BREATH FOR 12 HOURS * AntiCavity With Aloe Vera Net Wt. 4 oz. • 113.5 g MILD MINT Read back panel for current directions FIGHTS BAD BREATH FOR 12 HOURS* PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton

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