FDA.reportPublic FDA data

Treatment Rinse

Manufacturer
DENTAL ALLIANCE HOLDINGS LLC
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:13

Label at a glance#

ProductTreatment Rinse Apple
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct chi...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05% when mixed with part B

Purpose:

OTC - PURPOSE SECTION

Anticavity

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental caries (cavities)

Warnings:

WARNINGS SECTION

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. If you experience any unusual symptoms, stop use and contact your dentist.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

Treatment Rinse Mint and Apple enclosure and carton labels:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Principle Display PanelBox Principle Display PanelBox Principle Display PanelBox Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display PanelBottle Principle Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61578-314-012024-01-31C16284748780-11030e365-2b3b-111a-e063-dadaa90a10e2Treatment Rinse
61578-315-012024-01-31C16284748780-11030e365-2b3b-111a-e063-dadaa90a10e2Treatment Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-314-01Treatment RinseMint175.5 mL in 1 BOTTLE, PLASTICRINSE175.52
61578-314-01Treatment RinseMint2 in 1 PACKAGERINSE22
61578-315-01Treatment RinseApple2 in 1 PACKAGERINSE22
61578-315-01Treatment RinseApple175.5 mL in 1 BOTTLE, PLASTICRINSE175.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61578-314TREATMENT RINSE APPLE (ANTICARIES) RINSE TREATMENT RINSE MINT (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240202_f1255065-b7c3-4eb6-e053-2995a90afcdb.zip
61578-315TREATMENT RINSE APPLE (ANTICARIES) RINSE TREATMENT RINSE MINT (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240202_f1255065-b7c3-4eb6-e053-2995a90afcdb.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61578-31461578-314-01
61578-31561578-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
MENTHOLL7T10EIP3AIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
ndc (package): 61578-314-01
ndc (package): 61578-315-01
ndc (product): 61578-314
ndc (product): 61578-315
ndc11 (package): 61578031401
ndc11 (package): 61578031501
spl id: 1046e959-30aa-b3b3-e063-6294a90ada9a
spl set id: f1255065-b7c3-4eb6-e053-2995a90afcdb

Reported adverse events (FAERS/openFDA)#

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