FDA.reportPublic FDA data

Intensive Enamel Repair Whitening TP

Manufacturer
Topco Associates LLC | Lornamead Products | Lornamead
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:15:13

Label at a glance#

ProductIntensive Enamel Repair Whitening TP
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2821090R12821090R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN4
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD4
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY4
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-362-00Intensive Enamel Repair Whitening TP96.4 g in 1 TUBEPASTE, DENTIFRICE96.44
36800-362-00Intensive Enamel Repair Whitening TP1 in 1 CARTONPASTE, DENTIFRICE14
36800-362-10Intensive Enamel Repair Whitening TP1 in 1 CARTONPASTE, DENTIFRICE14
36800-362-10Intensive Enamel Repair Whitening TP96.4 g in 1 TUBEPASTE, DENTIFRICE96.44

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-36236800-362-00, 36800-362-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
PEG-8B697894SGQIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM SACCHARINSB8ZUX40TYIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM HYDROXIDE55X04QC32IIACT

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
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
ndc (package): 36800-362-00
ndc (package): 36800-362-10
ndc (product): 36800-362
ndc11 (package): 36800036200
ndc11 (package): 36800036210
spl id: 400555cb-e40f-5d08-e063-6394a90a160a
spl set id: 3012a8da-7595-2f7c-e063-6294a90ae120

Reported adverse events (FAERS/openFDA)#

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