CVS HEALTH SENSITIVE ENAMEL REPAIR- sodium fluoride paste, dentifrice

CVS Health Sensitive Enamel Repair by

Drug Labeling and Warnings

CVS Health Sensitive Enamel Repair by is a Otc medication manufactured, distributed, or labeled by CVS, 1000120219. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Potassium nitrate 5%

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

INDICATIONS & USAGE

Uses

• 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 indicare a seriuous 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 accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

• brus 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 snesitive 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

PURPOSE

Antihypersensitivity

Anticavity

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEALTH SENSITIVE ENAMEL REPAIR 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-169
Route of Administration	ORAL

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

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: 51316-169-10	1 in 1 CARTON	01/08/2026
1		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	M022	01/08/2026

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
1000120219		119559733	manufacture(51316-169) , pack(51316-169)