Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 817e804c-e55e-4d77-9ab9-ff54ae794725
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 Polyacrylic Acid (250000 Mw) Cocamidopropyl Betaine Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

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 or 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

parodontax ACTIVE GUM REPAIR

Plaque buildup on gums and teeth can lead to gum disease.

parodontax Active Gum Repair is a daily fluoride toothpaste formulated to help reverse signs of early gum disease by targeting plaque, the main cause of gum problems. It is 3xs more effective at removing plaque*

With a fresh minty flavor to enjoy every day.

*vs a sodium monofluorophosphate toothpaste with regular brushing

Targets plaque bacteria

Improves gum health

Fights early gum disease

Questions Or Comments?

1-866-844-2797

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

WHITENING

CLINICALLY PROVEN TO HELP REVERSE SIGNS OF EARLY GUM DISEASE:

✓ BLEEDING, ✓ REDNESS, ✓ SWELLING

NET WT 3.4 OZ (96.4 g)

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.
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 or 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 (Additional information)

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR

Plaque buildup on gums and teeth can lead to gum disease.

parodontax Active Gum Repair is a daily fluoride toothpaste formulated to help reverse signs of early gum disease by targeting plaque, the main cause of gum problems. It is 3xs more effective at removing plaque*

With a fresh minty flavor to enjoy every day.

*vs a sodium monofluorophosphate toothpaste with regular brushing

Targets plaque bacteria

Improves gum health

Fights early gum disease

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

WHITENING

CLINICALLY PROVEN TO HELP REVERSE SIGNS OF EARLY GUM DISEASE:

✓ BLEEDING, ✓ REDNESS, ✓ SWELLING

NET WT 3.4 OZ (96.4 g)

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.
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.


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