Drug Facts
Anticavity Oral Rinse
Therabreath Kit
FDA Label NDC 10237-274
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 10237-274). 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, anticavity oral rinse, directions, other information, 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
Whitening Oral Rinse
Keep out of reach of children under 12 years of age.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If spilled on fabrics, wash out immediately. This product was sealed with protective packaging. If seal is broken or missing, do not use.
Anticavity Oral Rinse
Keep out of the 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 and Children 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 for 30 minutes after rinsing.
Other Information
Do not use if safety seal is broken or missing
Rinses are not intended to be used together. Always read and follow the product labels.
Inactive Ingredients
water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, flavor, sodium benzoate, sucralose, xylitol, sodium bicarbonate
Therabreath Whitening Fresh Breath Oral Rinse Dazzling Mint
Directions
Package Label.Principal Display Panel
TheraBreath TM WHITENING + ANTICAVITY
VARIETY PACK
TheraBreath TM DENTIST FORMULATED
WHITENING DAZZLING MINT TM + ANTICAVITY SPARKLE MINT
ORAL RINSE VARIETY PACK
Helps remove stains and prevent future staining
Helps fight cavities for 12 hours*
*For cavity protection, use as directed.
2 BOTTLES 16 FL OZ (1 PT) 473 mL EACH;
32 FL OZ (1QT) 946mL TOTAL
IMPORTANT:
Read directions for proper use.
* Please review the disclaimer below.
