Drug Facts
Sodium fluoride 0.243%
(0.15% w/v fluoride ion)
Brisa
FDA Label NDC 73378-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haney, Inc. for the product Brisa (NDC 73378-003). 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, purpose, use, warning, directions, inactive ingredients, questions?, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity toothpaste
Use
helps protect against cavities
Warning
Keep out of reach of children under 6 yrs. of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
- do not swallow
- to minimize swallowing use a pea-sized amount in children under 6
- supervise children's brushing until good habits are established
- children under 2 yrs.: ask a dentist
Inactive Ingredients
water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, sucralose, polysorbate 80, titanium dioxide
Questions?
1-888-654-6409
Other
DISTR. BY/POR AGILE PURSUITS
CINCINNATI, OH 45202
116G Tube In Carton
brisa™
TOOTHPASTE
flouride toothpaste
Luminous Whitening
NET WT 4.1OZ (116g)
944 (944)
* Please review the disclaimer below.
