Label: PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT- sodium fluoride liquid
- NDC Code(s): 57660-003-01
- Packager: TJA Health LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 26, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
- Warnings
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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
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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:
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INGREDIENTS AND APPEARANCE
PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT
sodium fluoride liquidProduct 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)
