SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT- potassium nitrate and sodium fluoride paste 
SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION- potassium nitrate and sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Potassium nitrate 5%

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

Purpose

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), 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 (refreshing peppermint)

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin

Inactive ingredients (whitening action)

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions or comments?

1-866-844-2797

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 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

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 refreshing peppermint

NET WT 4.0 OZ (113g)

gsk

©2020 GSK group of companies or its licensor.

62000000049368

Sensodyne Pronamel Mineral Boost refreshing peppermint 4.0 oz carton

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 whitening action

NET WT 4.0 OZ (113g)

gsk

©2020 GSK group of companies or its licensor.

62000000049369

Sensodyne Pronamel Mineral Boost whitening action 4.0 oz carton
SENSODYNE PRONAMEL  MINERAL BOOST REFRESHING PEPPERMINT
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0450
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0450-011 in 1 CARTON01/04/2021
1118 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/04/2021
SENSODYNE PRONAMEL  MINERAL BOOST WHITENING ACTION
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0480-011 in 1 CARTON01/04/2021
1118 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0480-021 in 1 CARTON01/04/2021
277 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/04/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2020
Document Id: b6b53ab0-82ee-459a-be1a-14e12c2582f5
Set id: b6b53ab0-82ee-459a-be1a-14e12c2582f5
Version: 1
Effective Time: 20200825
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC