Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 0f07aa1a-97be-44af-92d8-a10777e24e0a
Route
DENTAL
Published
Effective Date 2025-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.10 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate Anhydrous Sodium Lauryl Sulfate Titanium Dioxide Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Cocamidopropyl Betaine Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-19 Until 2024-12-31

Description

Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)

Purpose

Anticavity Antigingivitis


Medication Information

Purpose

Anticavity Antigingivitis

Description

Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)

Uses
  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • helps interfere with harmful effects of plaque associated with gingivitis.
Purposes

Anticavity

Antigingivitis

Directions
  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or doctor. Minimize swallowing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age: Consult a dentist or doctor.
Active Ingredient

Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this product is specially formulated to help prevent staining.
  • do not store above 25ºC (77ºF)
Inactive Ingredients

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Additional Information

ALWAYS FOLLOW THE LABEL

Healthy gums don’t bleed

If you spit blood when you brush or floss, it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums* by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath, and whitens – for healthy gums and strong teeth.

parodontax toothpaste offers a fresh, minty flavor.

*with twice daily brushing

Unhealthy gums

Healthy gums

ADA Accepted

American Dental Association ®

Questions Or Comments?

Call toll-free 1-866-844-2797

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel Clean Mint

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

CLEAN MINT

DAILY GUM CARE

HELPS CONTROL BLEEDING GUMS

NET WT 3.4 OZ (96.4 g)

Principal Display Panel – Whitening

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

WHITENING

DAILY GUM CARE

HELPS CONTROL BLEEDING GUMS

NET WT 3.4 OZ (96.4 g)

Principal Display Panel – Extra Fresh

CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

NDC 0135-0599-02

parodontax

EXTRA FRESH

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

Helps prevent bleeding gums

NET WT

3.4 OZ (96.4 g)

PLAQUE BUILDS UP

GUMS SWELL AND BLEED

PARODONTAX HELPS REMOVE PLAQUE

Healthy gums don’t bleed

If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • helps interfere with harmful effects of plaque associated with gingivitis.
Purposes

Anticavity

Antigingivitis

Directions
  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or doctor. Minimize swallowing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
  • children under 2 years of age: Consult a dentist or doctor.
Active Ingredient (Active ingredient)

Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)

Other Information (Other information)
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this product is specially formulated to help prevent staining.
  • do not store above 25ºC (77ºF)
Inactive Ingredients (Inactive ingredients)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Additional Information

ALWAYS FOLLOW THE LABEL

Healthy gums don’t bleed

If you spit blood when you brush or floss, it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums* by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath, and whitens – for healthy gums and strong teeth.

parodontax toothpaste offers a fresh, minty flavor.

*with twice daily brushing

Unhealthy gums

Healthy gums

ADA Accepted

American Dental Association ®

Questions Or Comments? (Questions or comments?)

Call toll-free 1-866-844-2797

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel Clean Mint (Principal Display Panel - Clean Mint)

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

CLEAN MINT

DAILY GUM CARE

HELPS CONTROL BLEEDING GUMS

NET WT 3.4 OZ (96.4 g)

Principal Display Panel – Whitening

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

WHITENING

DAILY GUM CARE

HELPS CONTROL BLEEDING GUMS

NET WT 3.4 OZ (96.4 g)

Principal Display Panel – Extra Fresh

CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

NDC 0135-0599-02

parodontax

EXTRA FRESH

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

Helps prevent bleeding gums

NET WT

3.4 OZ (96.4 g)

PLAQUE BUILDS UP

GUMS SWELL AND BLEED

PARODONTAX HELPS REMOVE PLAQUE

Healthy gums don’t bleed

If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)