Active Ingredient
SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)
Discount Drug Mart
FDA Label NDC 53943-554
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Discount Drug Mart (NDC 53943-554). 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, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTIPLAQUE
Uses
AIDS IN THE PREVENTION OF DENTAL CAVITIES
Warnings
Keep Out Of Reach Of Children
IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
Directions
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE. VIGOROUSLY SWISH 10 ML 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. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 6 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR
Other Information
STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED
Inactive Ingredients
CALCIUM DISODIUM EDTA, CETYLPYRIDINIUM CHLORIDE, DISODIUM PHOSPHATE, FLAVOR, GREEN 3 (CI 42053), MENTHOL, METHYL SALICYLATE, POLOXAMER 407, POLYSORBATE 20, POTASSIUM SORBATE, PROPYLENE GLYCOL, SODIUM BENZOATE, SODIUM PHOSPHATE, SODIUM SACCHARIN, SORBITOL, WATER (AQUA), YELLOW 5 (CI 19140).
Label Copy
Image Of The Label (19539l)
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