SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH FRESH BREATH- potassium nitrate, sodium fluoride paste, dentifrice

Sensodyne by

Drug Labeling and Warnings

Sensodyne by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Potassium nitrate 5%

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

Purposes

Antihypersensitivity

Anticavity

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

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

Directions

• 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 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing.
• children under 12 years of age:Consult a dentist or doctor.

Other information

• do not store above 25°C (77°F)

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions or comments?

1-866-844-2797

Additional Information

ALWAYS FOLOW THE LABEL

SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH

CLINICALLY PROVEN ENAMEL STRENGTHENING

REPAIRS

66%of enamel microdamage in the most vulnerable areas of your teeth^

24/7 PROTECTION

against early stage cavities, sensitivity and future enamel damage**

To help protect teeth for life**

LEAVES YOUR MOUTH

feeling clean and fresh

FRESH MINT

*Vs. your mouth’s natural defenses.

**With twice daily brushing.

^Acid weakened enamel. On average as shown in 7 day lab test.

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

SENSODYNE PRONAMEL

3x STRONGER ENAMEL PROTECTION*

CLINICAL ENAMEL STRENGTH

#1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

FRESH BREATH

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

SENSODYNE   PRONAMEL CLINICAL ENAMEL STRENGTH FRESH BREATH
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-7753
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LACTATE (UNII: TU7HW0W0QT)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (1750000 WAMW) (UNII: 9F20VSM0VU)
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: 0135-7753-01	1 in 1 CARTON	12/01/2025
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	M021	12/01/2025

Labeler - Haleon US Holdings LLC (079944263)