PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT- sodium fluoride liquid

Plaque Refresh Remineralizing Rinse Fresh Mint by

Drug Labeling and Warnings

Plaque Refresh Remineralizing Rinse Fresh Mint by is a Otc medication manufactured, distributed, or labeled by TJA Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Purpose

Anticavity

Use

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 right away.

Directions

- Adults and children 12 years of age or older:
- use twice daily after brushing your teeth
- vigorously swish 10 mL (2 teaspoonfuls) 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
- Children under 12 year of age: consult a dentist or doctor

Other information

- store at room temperature
- cold weather may temporarily cloud this product

Inactive ingredients

Water, sorbitol, vegetable glycerin, xylitol, poloxamer-407, polysorbate-20, sodium bicarbonate (baking soda), aloe barbadensis leaf juice extract, persea gratissima (avocado) oil, tocopherol acetate (natural vitamin E), mentha viridis (spearmint) leaf oil, mentha piperita (peppermint) oil, melaleuca alternifolia (tea tree) leaf oil, citrus paradisi (grapefruit) seed oil, eucalyptus globulus leaf oil, menthol, thymol, gaultheria procumbens (wintergreen) leaf oil, bixa orellana (annatto) seed extract, PVP, calcium lactate, tetrasodium pyrophosphate, sodium  hexametaphosphate, blue no.1, zinc citrate, sodium benzoate, sodium gluconate, phosphoric acid, cellulose gum, disodium EDTA.

Package Labeling:

INGREDIENTS AND APPEARANCE

PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57660-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
THYMOL (UNII: 3J50XA376E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
BIXA ORELLANA SEED (UNII: O87354RZ5A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CALCIUM LACTATE (UNII: 2URQ2N32W3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57660-003-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2022

Labeler - TJA Health LLC (078799634)