PRONAMEL REPAIR WHITENING- fluoride paste, dentifrice

Pronamel Repair Whitening by

Drug Labeling and Warnings

Pronamel Repair Whitening by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Potassium nitrate 5% .................................................. Antihypersensitivity

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

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 stil persists after 4 weeks of use.

PURPOSE

Anthihypersensitivity

Anticavity

INDICATIONS & USAGE

builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

If more than used for brushing is accidentaly 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 ontp 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 
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6310
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6310-1	1 in 1 CARTON	12/01/2024
1		96 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	12/01/2024

Labeler - Rite Aid (014578892)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(11822-6310) , pack(11822-6310)