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DISCOUNT DRUG MART

DISCOUNT DRUG MART
APOLLO HEALTH AND BEAUTY CARE

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

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

DISCOUNT DRUG MART

DISCOUNT DRUG MART

SODIUM FLUORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53943-554
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.5 mg

Inactive Ingredients

Ingredient Name Strength
edetate calcium disodium
cetylpyridinium chloride
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C GREEN NO. 3
MENTHOL
methyl salicylate
POLOXAMER 407
POLYSORBATE 20
POTASSIUM SORBATE
propylene glycol
SODIUM BENZOATE
sodium phosphate
saccharin sodium
sorbitol
water
FD&C YELLOW NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53943-554-18 532 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2014-05-15


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