Active Ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
Therabreath Complete Oral Rinse
FDA Label NDC 10237-267
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 Complete Oral Rinse (NDC 10237-267). 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, use, otc - keep out of reach of children, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults 18 years of age and older:
• use twice 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
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, flavor, sodium benzoate, sucralose, sodium bicarbonate
Package Label.Principal Display Panel
NO ALCOHOL,
NON BURNING
ANTICAVITY FLUORIDE RINSE
THERABREATH TM
DENTIST FORMULATED
COMPLETE
ORAL RINSE
6 BENEFITS IN 1
Fights Cavities • Freshens Breath
Kills Bad Breath Bacteria • Cleans Whole Mouth
Strengthens Teeth • Helps Rebuild Enamel
Dr. Harold Katz
REVITALIZING MINT
IMPORTANT: Read directions for proper use.
16 fl. oz. (1 pt.) 473 mL
* Please review the disclaimer below.
