Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 94e07979-943b-45bb-8e2b-90d686f3692e
Route
DENTAL
Published
Effective Date 2024-09-04
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 Hydrated Silica Sorbitol Glycerin Polyethylene Glycol 400 Cocamidopropyl Betaine Xanthan Gum Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-15

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.
Purposes

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.
Generic Section

SENSODYNE PRONAMEL

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

* removes stains

ALWAYS FOLLOW THE LABEL

CARTON RECYCLE

TUBE RECYCLE

CAP† CHECK LOCALLY

† Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap†

SPECIALIST ENAMEL PROTECTION

The acids in your diet can damage tooth enamel, leading to dull, yellow teeth.

Wine Acids

Fruit Acids

Soda Acids

Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white.

SENSODYNE PRONAMEL

POWERFUL WHITENING*

GENTLE ON ENAMEL

#1 DENTIST RECOMMENDED ENAMEL BRAND

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

Potassium nitrate 5%

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

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions Or Comments?

1-866-844-2797

Principal Display Panel

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED

POWERFUL WHITENING*,

GENTLE ON ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

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.

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.

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.
Purposes

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.
Generic Section

SENSODYNE PRONAMEL

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

* removes stains

ALWAYS FOLLOW THE LABEL

CARTON RECYCLE

TUBE RECYCLE

CAP† CHECK LOCALLY

† Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap†

SPECIALIST ENAMEL PROTECTION

The acids in your diet can damage tooth enamel, leading to dull, yellow teeth.

Wine Acids

Fruit Acids

Soda Acids

Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white.

SENSODYNE PRONAMEL

POWERFUL WHITENING*

GENTLE ON ENAMEL

#1 DENTIST RECOMMENDED ENAMEL BRAND

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

Potassium nitrate 5%

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

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED

POWERFUL WHITENING*,

GENTLE ON ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

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.

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.

Advanced Ingredient Data


Raw Label Data

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