Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID addcb1e2-24b9-4367-adf3-6806e2439a80
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 Zinc Chloride Carrageenan

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-02

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, zinc chloride, carrageenan

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR

Bleeding, redness, swelling, and bad breath can be signs of gum disease.

parodontax Active Gum Repair Breath Freshener is a daily fluoride toothpaste that reduces signs of early gum disease and uses Breath Cleanse Technology to purify bad breath instead of just masking it. Specially formulated to kill plaque bacteria at the gumline to help keep the gum seal tight.

Its Breath Cleanse Technology utilizes zinc, an ingredient clinically proven to purify the gases that cause bad breath.

*vs. a regular toothpaste used by people who have gingivitis

Targets plaque bacteria

Fights early gum problems

Reduces bad breath

breathcleanse TECHNOLOGY

Questions Or Comments?

1-855-328-5202

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

BREATH FRESHENER

CLINICALLY PROVEN TO REDUCE SIGNS OF EARLY GUM DISEASE*:

✓ BLEEDING ✓ REDNESS ✓ SWELLING ✓BAD BREATH

breathcleanse

TECHNOLOGY

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, zinc chloride, carrageenan

Additional Information (Additional information)

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR

Bleeding, redness, swelling, and bad breath can be signs of gum disease.

parodontax Active Gum Repair Breath Freshener is a daily fluoride toothpaste that reduces signs of early gum disease and uses Breath Cleanse Technology to purify bad breath instead of just masking it. Specially formulated to kill plaque bacteria at the gumline to help keep the gum seal tight.

Its Breath Cleanse Technology utilizes zinc, an ingredient clinically proven to purify the gases that cause bad breath.

*vs. a regular toothpaste used by people who have gingivitis

Targets plaque bacteria

Fights early gum problems

Reduces bad breath

breathcleanse TECHNOLOGY

Questions Or Comments? (Questions or comments?)

1-855-328-5202

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

BREATH FRESHENER

CLINICALLY PROVEN TO REDUCE SIGNS OF EARLY GUM DISEASE*:

✓ BLEEDING ✓ REDNESS ✓ SWELLING ✓BAD BREATH

breathcleanse

TECHNOLOGY

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.


Advanced Ingredient Data


Raw Label Data

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