Active Ingredients
Sodium Fluoride 0.24%
(0.14% W/V fluoride ion)
Therabreath Fresh Breath
FDA Label NDC 72551-250
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Harold Katz, Llc for the product Therabreath Fresh Breath (NDC 72551-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, directions, warnings, other information, inactive ingredients, therabreath fresh breath, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity Fluoride Dentrifice
Uses
Aids in the prevention of dental cavities
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.
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age.
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.
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 (OXYD-8™), Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)
* Please review the disclaimer below.
