Exceed Total Care Sensitive

Manufacturer
Melaleuca, Inc
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:43

Label at a glance#

ProductExceed Total Care Sensitive Spearmint Tooth Polish
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses

  • aids in the prevention of dental cavaties
  • helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS SECTION

Warnings

  • Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
  • Sensitivt teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age or older: apply at least a 1-inch strup of the tooth polish onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Be sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients water, hydrated silica, glycerin, sorbitol, flavor, xanthan gum, stevia leaf extract, propanediol, poloxamer 407, zinc citrate, tetrasocium pyrophosphate, titanium dioxide, lauramidopropyl betaine, benzyl alcohol, sodium hydroxide, melaleuca alternifolia (tea tree) leaf oil.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Sodium fluoride (0.243%w/w)........................Anticavity

Potassium nitrate (5.0%w/w)...................Antisensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-337-04Exceed Total Care SensitiveSpearmint Tooth Polish93.5 g in 1 TUBEPASTE, DENTIFRICE93.53

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-33754473-337-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
ndc (package): 54473-337-04
ndc (product): 54473-337
ndc11 (package): 54473033704
spl id: 4746b4ab-584f-7572-e063-6394a90a971d
spl set id: dc620d3f-880f-df05-e053-2995a90a8409

Reported adverse events (FAERS/openFDA)#

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