FDA Label for Therabreath Healthy Smile Oral Rinse
View Indications, Usage & Precautions
Therabreath Healthy Smile Oral Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Dr. Harold Katz, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
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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