Amber Mouth Rinse description, usages, side effects, indications, overdosage, supplying and lots more!

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Amber Mouth Rinse

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NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Amber Mouth Rinse

Amber Mouth Rinse

EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50438-303
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
EUCALYPTOL EUCALYPTOL 0.92 mg
MENTHOL 0.42 mg
methyl salicylate METHYL SALICYLATE 0.6 mg
THYMOL THYMOL 0.64 mg

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL
sorbitol
POLOXAMER 407
BENZOIC ACID
saccharin sodium
SODIUM BENZOATE
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50438-303-01 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-07-30


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