DailyMed - SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT- potassium nitrate and sodium fluoride paste SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION- potassium nitrate and sodium fluoride paste

NDC Code(s): 0135-0450-01, 0135-0480-01, 0135-0480-02
Packager: Haleon US Holdings LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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Active ingredient
Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)
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Purpose
Antihypersensitivity - Anticavity

Antihypersensitivity

Anticavity
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Uses
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- aids in the prevention of dental cavities.
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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 ...
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.

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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 ...
- 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), 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.
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Other information
do not store above 25°C (77°F)
- do not store above 25°C (77°F)
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Inactive ingredients (refreshing peppermint)
water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin
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Inactive ingredients (whitening action)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide
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Questions or comments?
1-866-844-2797

1-866-844-2797
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Additional Information
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide - Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva ...
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss.

Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity.

ACIDS DISSOLVE SURFACE MINERALS…

…PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA

Replenishes vital minerals in enamel.

Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface.

With twice-daily brushing, Pronamel helps to:
- Protect against effects of dietary acids
- Prevent enamel loss
- Relieve sensitive teeth
- Protect against cavities
- Clean and freshen your mouth
Recyclable Carton

Save Water

Turn off tap while brushing

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059
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Principal Display Panel
NDC 0135-0450-01 - SENSODYNE - PRONAMEL - MINERAL BOOST - new - TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION - Replenishes Vital Minerals - For Stronger, Healthier Enamel - infused with ...

NDC 0135-0450-01

SENSODYNE

PRONAMEL

MINERAL BOOST

new

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Replenishes Vital Minerals

For Stronger, Healthier Enamel

infused with refreshing peppermint

NET WT 4.0 OZ (113g)

gsk

©2020 GSK group of companies or its licensor.

62000000049368

Close
Principal Display Panel
NDC 0135-0480-01 - SENSODYNE - PRONAMEL - MINERAL BOOST - new - TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION - Replenishes Vital Minerals - For Stronger, Healthier Enamel - With gentle ...

NDC 0135-0480-01

SENSODYNE

PRONAMEL

MINERAL BOOST

new

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Replenishes Vital Minerals

For Stronger, Healthier Enamel

With gentle whitening action

NET WT 4.0 OZ (113g)

gsk

©2020 GSK group of companies or its licensor.

62000000049369

Close

INGREDIENTS AND APPEARANCE

Product Information

SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0450
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	1.15 mg in 1 g

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0450-01	1 in 1 CARTON	01/04/2021
1		118 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/04/2021

SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0480
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	1.15 mg in 1 g

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0480-01	1 in 1 CARTON	01/04/2021
1		118 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0480-02	1 in 1 CARTON	01/04/2021
2		77 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	01/04/2021

Labeler - Haleon US Holdings LLC (079944263)

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Published Date (What is this?)	Version	Files
Mar 6, 2024	2 (current)	download
Jan 4, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1086243	potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste	PSN
2	1086243	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste	SCD
3	1086243	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY
4	1086243	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Stop use and ask a dentist if

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	0135-0450-01
2	0135-0480-01
3	0135-0480-02

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Stop use and ask a dentist if

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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