Active Ingredient
SODIUM MONOFLUOROPHOSPHATE 0.88% (W/W)
Luster Power White
FDA Label NDC 57353-106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dentovations Inc for the product Luster Power White (NDC 57353-106). 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, directions, otc - keep out of reach of children, warnings, other safety information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTI-CAVITY
Use
HELPS PROTECT AGINST CAVITIES
Directions
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER:
FOR THE BEST RESULTS BRUSH TEETH THOROUGHLY, PREFERABLY AFTER EACH MEAL OR AT LEAST TWICE A DAY, OR AS DIRECTED BY A DENTIST OR DOCTOR. DO NOT SWALLOW. PRODUCT IS NOT RECOMMENDED FOR USE BY CHILDREN UNDER 12 YEARS OF AGE.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.
Warnings
IF MORE THAN THE AMOUNT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. AVOID CONTACT OF THE PRODUCT WITH THE EYE. IF IRRITATION (SUCH AS REDNESS, SWELLING, SORENESS) OF THE GUM OR THE MOUTH OCCURS, DISCONTINUE USE AND CONSULT A DENTIST.
Other Safety Information
OTHER INFORMATION: STORE BELOW 80°F (27°C).
Inactive Ingredients
VEGETABLE GLYCERIN, CALCIUM PYROPHOSPHATE, ZEA MAYS (CORN) STARCH, PROPYLENE GLYCOL, PEG-12, WATER, HYDROGEN PEROXIDE, SODIUM LAUROYL SARCOCINATE, FLAVOR, CELLULOSE GUM, CARBOMER, SODIUM SACCHARIN, PIROCTONE OLAMINE
Otc - Questions
QUESTIONS OR COMMENTS?
CALL 1-800-823-5727 (M-F 9 A.M. - 5 P.M. EST)
VISIT LUSTERPREMIUMWHITE.COM, EMAIL [email protected],
OR FOLLOW: @LUSTERPREMWHITE
Package Label.Principal Display Panel
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