SENSODYNE CLINICAL WHITE STAIN PROTECTOR- potassium nitrate, sodium fluoride paste SENSODYNE CLINICAL WHITE ENAMEL STRENGTHENING- potassium nitrate, sodium fluoride paste

Sensodyne by

Drug Labeling and Warnings

Sensodyne by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) 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 betaine, sodium hydroxide, carrageenan, sodium saccharin

Questions or comments?

1-866-844-2797

Other (Enamel Strengthening)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL
WHITE

CLINICAL PROVEN
WHITENING
DESIGNED FOR
SENSITIVE TEETH

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

Strengthens enamel

ENAMEL SAFE

* As shown in an 8 week study.
** With twice daily brushing.

Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
© 2023 Haleon or licensor.

Other (Stain Protector)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL
WHITE

CLINICAL 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

Helps protect teeth from future stains

ENAMEL SAFE

* As shown in an 8 week study.
** With twice daily brushing.

Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
© 2023 Haleon or licensor.

Principal Display Panel (Enamel Strengthening)

NEW

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

SENSODYNE

TOOTHPASE FOR SENSITIVE TEETH AND CAVITY PREVENTION

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

ENAMEL STRENGTHENING

NET WT 2.3 OZ (65.2 g)

Principal Display Panel (Stain Protector)

NEW

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

2 SHADES WHITER TEETH*
+24/7 SENSITIVITY PROTECTION**

CLINICAL
WHITE

STAIN PROTECTOR

NET WT 3.4 OZ (96.4 g)

INGREDIENTS AND APPEARANCE

SENSODYNE  CLINICAL WHITE STAIN PROTECTOR
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0702
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)	FLUORIDE ION	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODA LIME (UNII: 4RG4VJM6VG)
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: 0135-0702-01	1 in 1 CARTON	01/02/2024
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0702-02	1 in 1 CARTON	01/02/2024
2		62.5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0702-03	1 in 1 CARTON	01/02/2024
3		23 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0135-0702-04	2 in 1 CARTON	01/02/2024
4		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	01/02/2024

SENSODYNE  CLINICAL WHITE ENAMEL STRENGTHENING
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0703
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)	FLUORIDE ION	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODA LIME (UNII: 4RG4VJM6VG)
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: 0135-0703-01	1 in 1 CARTON	01/02/2024
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0703-02	1 in 1 CARTON	01/02/2024
2		62.5 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	01/02/2024

Labeler - Haleon US Holdings LLC (079944263)