PRONAMEL REPAIR WHITENING paste, dentifrice

Pronamel Repair Whitening by

Drug Labeling and Warnings

Pronamel Repair Whitening by is a Otc medication manufactured, distributed, or labeled by Publix Super Market Inc, 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, of iffitation occurs discontine use.

Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty still persists after 4 weeks of use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for brushing is accidently swallowed, get medical help or contact a Posion 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

PRONAMEL REPAIR WHITENING 
pronamel repair whitening paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-514
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-514-44	1 in 1 CARTON	09/01/2024
1		96.3 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	M022	09/01/2024

Labeler - Publix Super Market Inc (006922009)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	pack(56062-514) , manufacture(56062-514)