Sensitive

Manufacturer
Melaleuca, Inc.
Effective date
2018-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:04

Label at a glance#

ProductSensitive Tooth Polish
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Potassium nitrate (5.0% w/w)
Sodium fluoride (0.243% w/w)

OTC - PURPOSE SECTION

Purpose
Antisensitivity
Anticavity

INDICATIONS & USAGE SECTION

Uses

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • aids in the prevention of cavities

WARNINGS SECTION

Warnings
When using this product do not use longer than four weeks unless recommended by a dentist

OTC - STOP USE SECTION

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

PRECAUTIONS SECTION

Other information

This product contains papain, which may cause allergic reactions

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN1
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD1
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY1
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY1
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-302-04SensitiveTooth Polish108 g in 1 TUBEPASTE, DENTIFRICE1081

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-302SENSITIVE TOOTH POLISH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC.]1Current NDC, Legacy NDC, 1 package rows20180330_689349e4-3980-a0e4-e053-2991aa0a9ef5.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-30254473-302-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML · Source PDF

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
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
ndc (package): 54473-302-04
ndc (product): 54473-302
ndc11 (package): 54473030204
spl id: 68933f55-0cd9-0074-e053-2991aa0adfb7
spl set id: 689349e4-3980-a0e4-e053-2991aa0a9ef5

Reported adverse events (FAERS/openFDA)#

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