Jason Healthy Mouth Anticavity Tartar Control Tea Tree Cinnamon

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:39:37

Label at a glance#

ProductJason Healthy Mouth Anticavity Tartar Control Tea Tree Cinnamon
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Anticavity

WARNINGS SECTION

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Prevent plaque and tartar buildup with regular drushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

INACTIVE INGREDIENT SECTION

Glycerin, Aqua (Water), Hydrated Silica, Sodium Cocoyl Glutamate, Xylitol, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Melia Azadirachta Seed Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Stem Extract, Ascorbic Acid, Tocopheryl Acetate, Calcium Carbonate, Cellulose Gum, Citric Acid, Menthol, Sea Salt, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone, Eugenol

(1) Certified Organic Ingredients

(2) Coenzyme Q10

INDICATIONS & USAGE SECTION

Use: Prevention of cavities

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton labeltube labeltube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-0525-62023-01-30C16284748780-1ba0f9c33-472b-a910-e053-dadaa90a0b85Healthy Mouth Toothgel
61995-0525-62021-02-05C16284748780-1ba0f9c33-472b-a910-e053-dadaa90a0b85Healthy Mouth Toothgel
61995-0525-62021-01-29C16284748780-1ba0f9c33-472b-a910-e053-dadaa90a0b85Healthy Mouth Toothgel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0525-6Jason Healthy Mouth Anticavity Tartar Control Tea Tree Cinnamon1 in 1 CARTONGEL14
61995-0525-6Jason Healthy Mouth Anticavity Tartar Control Tea Tree Cinnamon170 g in 1 TUBEGEL1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0525JASON HEALTHY MOUTH ANTICAVITY TARTAR CONTROL TEA TREE CINNAMON (SODIUM MONOFLUOROPHOSPHATE) GEL [THE HAIN CELESTIAL GROUP, INC.]4Legacy NDC, 2 package rows20210413_6627017b-d533-1b67-e053-2a91aa0afd54.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-052561995-0525-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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
bfc9048a-5df5-3220-e053-2a95a90ac6776627017b-d533-1b67-e053-2a91aa0afd542021-04-12WarningsExact identifier
spl id: bfc9048a-5df5-3220-e053-2a95a90ac677
spl set id: 6627017b-d533-1b67-e053-2a91aa0afd54

Reported adverse events (FAERS/openFDA)#

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