Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Therabreath Healthy Smile Oral Rinse
FDA Label NDC 72551-246
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 Healthy Smile Oral Rinse (NDC 72551-246). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, therabreath healthy smile oral rinse, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children 6 years of age and older:
- Use once a day after 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.
- Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: consult a dentist or doctor.
Other Information
Do not use if safety seal is broken or missing.
Inactive Ingredients
Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate.
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