DISCOUNT DRUG MART ANTICAVITY FLUORIDE RINSE MINT FLAVOR- sodium fluoride liquid
DISCOUNT DRUG MART

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.

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DRUG FACTS

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

IMAGE OF THE LABEL

DISCOUNT DRUG MART ANTICAVITY FLUORIDE RINSE MINT FLAVOR
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53943-554
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/15/2014

Labeler - DISCOUNT DRUG MART (047741335)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(53943-554)