SENSODYNE CLINICAL WHITE INTENSIVE CLEAN- potassium nitrate, sodium fluoride paste

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 thorough for at least 1 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.

Other information

• do not store above 25°C (77°F)

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betain, sodium hydroxide, carrageenan, sodium saccharin

Questions or comments?

1-866-844-2797

Generic Section

ALWAYS FOLLOW THE LABEL

SENSODYNE

WHITE

CLINICALLY PROVEN WHITENING DESIGNED FOR SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel

7X BETTER CLEANING^

Through stain removal

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

^ After 8 weeks twice daily brushing as compared to a non-whitening toothpaste.

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+ 24/7 SENSITIVITY PROTECTION**

CLINICAL WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

INTENSIVE CLEAN

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

SENSODYNE  CLINICAL WHITE INTENSIVE CLEAN
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-5468
Route of Administration	ORAL

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	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
PEG-8 MONOSTEARATE (UNII: 2P9L47VI5E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: 0135-5468-01	1 in 1 CARTON	12/31/2024
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-5468-03	3 in 1 CARTON	12/31/2024
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	M022	12/31/2024

Labeler - Haleon US Holdings LLC (079944263)