PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT- sodium fluoride liquid 
TJA Health LLC

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Plaque Refresh Remineralizing Rinse Fresh Mint

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:

Label

PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57660-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57660-003-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02101/01/2022
Labeler - TJA Health LLC (078799634)

Revised: 12/2023
Document Id: 0d77552d-f0ac-de1c-e063-6394a90a1c45
Set id: bc1f90da-468c-43aa-b639-fb457070f42f
Version: 2
Effective Time: 20231226
 
TJA Health LLC