INTENSIVE ENAMEL REPAIR WHITENING TP paste, dentifrice

Intensive Enamel Repair Whitening TP by

Drug Labeling and Warnings

Intensive Enamel Repair Whitening TP by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Lornamead Products, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Potassium nitrate 5%

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

PURPOSE

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

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

WARNINGS

When using this product, if irritation occurs discontinue use.

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.

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTENSIVE ENAMEL REPAIR WHITENING TP 
intensive enamel repair whitening tp paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-362
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-362-00	1 in 1 CARTON	06/17/2025	09/30/2025
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 36800-362-10	1 in 1 CARTON	09/30/2025
2		96.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/17/2025

Labeler - Topco Associates LLC (006935977)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		119559733	manufacture(36800-362) , pack(36800-362)