Plaque Refresh Remineralizing Rinse Fresh Mint

Manufacturer
TJA Health LLC
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:02:01

Label at a glance#

ProductPlaque Refresh Remineralizing Rinse Fresh Mint
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

- 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4
313029sodium fluoride 0.2 MG/ML MouthwashSCD4
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57660-003-012025-02-12C16284748780-12cef2736-ae92-d83d-e063-dadaa90ab31fPlaque Refresh Remineralizing Rinse Fresh Mint
57660-003-012025-01-30C16284748780-12cef2736-ae92-d83d-e063-dadaa90ab31fPlaque Refresh Remineralizing Rinse Fresh Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57660-003-01Plaque Refresh Remineralizing Rinse Fresh Mint473 mL in 1 BOTTLELIQUID4734

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57660-00357660-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
365ba7ef-90fa-4437-e063-6294a90aec00bc1f90da-468c-43aa-b639-fb457070f42f2025-05-30WarningsExact identifier
spl id: 365ba7ef-90fa-4437-e063-6294a90aec00
spl set id: bc1f90da-468c-43aa-b639-fb457070f42f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.