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Royal Mouthwash Fresh and Clean Original Mint

Dosage form: liquid
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.6mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Filo America
NDC Code: 50438-304

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT 
eucalyptol, menthol, methyl salicylate, thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-304
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.6 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:50438-304-011000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/17/2013
Labeler - Filo America (943873703)
Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
Establishment
NameAddressID/FEIOperations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-304)

Revised: 09/2013
 
Filo America

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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