Active Ingredient
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%
Amber Mouth Rinse
FDA Label NDC 50438-303
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Amber Mouth Rinse (NDC 50438-303). 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/ANTIGINGIVITIS
Uses
TO HELP CONTROL PLAQUE THAT LEADS TO GINGIVITIS.
Warnings
DO NOT USE IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE.
DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.
STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS.
Keep Out Of 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 12 YEARS OF AGE AND OLDER.
VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T OUT;DO NOT SWALLOW.
CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DENTIST OR DOCTOR.
THIS RINSE IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING.
Other Information
COLD WATER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED. STORE AT ROOM TEMPERATURE (59°-77°F).
Inactive Ingredients:
WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 5, BLUE 1
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