Active Ingredient
Sodium fluoride 0.243%
Burst
FDA Label NDC 71275-001
8 label sections · Submitted to the FDA by Burst.usa.inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burst.usa.inc for the product Burst (NDC 71275-001). 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, uses, keep out of the reach of children, warnings, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities
Keep Out Of The Reach Of Children
under 6 years of age.
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 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician
Inactive Ingredients
benzyl alcohol, cellulose gum, flavor, glycerin, PEG-32, propylene glycol, PVM/MA copolymer, silica, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum
Package Label
Package Label (Bursttthpstelbl)
* Please review the disclaimer below.
