FDA Label for Peppermint Mouth Rinse
View Indications, Usage & Precautions
Peppermint Mouth Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Filo America. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%
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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