Drug Facts
Overnight Oral Rinse
Therabreath Kit
FDA Label NDC 10237-268
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Therabreath (NDC 10237-268). 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 drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get help or contact a Poison Control Center right away.
Directions
Adults 18 years of age or 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 30 minutes after rinsing
Inactive Ingredients
water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor
Principal Display Panel
TheraBreath AM + PM TWIN PACK
AM
POWERED BY OXYGEN TM
INVIGORATING ICY MINT
PM
ANTICAVITY FLUORIDE RINSE
CHAMOMILE MINT
Helps prvent cavities and rebuild enamel
Add TheraBreath to your swishy time routine both day + night!
Fights bad breath for 12 hours
* Please review the disclaimer below.
