Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b6b53ab0-82ee-459a-be1a-14e12c2582f5
Route
ORAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.15 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Cocamidopropyl Betaine Xanthan Gum Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-04

Description

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

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

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

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

Potassium nitrate 5%

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

Other Information
  • do not store above 25°C (77°F)
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

Questions Or Comments?

1-866-844-2797

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

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.

Inactive Ingredients (whitening Action)

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

Inactive Ingredients (refreshing Peppermint)

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


Structured Label Content

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

Antihypersensitivity

Anticavity

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.
Active Ingredient (Active ingredient)

Potassium nitrate 5%

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

Other Information (Other information)
  • do not store above 25°C (77°F)
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

Questions Or Comments? (Questions or comments?)

1-866-844-2797

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

Stop Use and Ask A Dentist If (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. (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.

Inactive Ingredients (whitening Action) (Inactive ingredients (whitening action))

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

Inactive Ingredients (refreshing Peppermint) (Inactive ingredients (refreshing peppermint))

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


Advanced Ingredient Data


Raw Label Data

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