Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 59bb84d6-6fd3-4586-bccf-7dc45cbbb39c
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 2018-11-01

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:
    • apply toothpaste onto a toothbrush.
    • 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, sodium saccharin, cocamidopropyl betaine

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax COMPLETE PROTECTION

Bleeding, redness, and swelling can be signs of unhealthy gums, eventually weakening the foundation of your teeth.

parodontax Complete Protection builds on the gum health expertise behind our dentist recommended daily fluoride toothpaste – providing 8 benefits designed for healthy gums and strong teeth.

With a fresh minty flavor to enjoy every day.

8 BENEFITS FOR HEALTHY GUMS & STRONG TEETH

Gently whitens

Deep cleans

Helps prevent bleeding gums

Effectively removes plaque

Strengthens and protects enamel

Freshens breath

Works to keep the seal between gums and teeth tight

Reduces red and inflamed gums

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

PURE FRESH MINT

COMPLETE PROTECTION

8 BENEFITS

  • REDUCES BLEEDING GUMS
  • REDUCES INFLAMED GUMS
  • GUM SEAL
  • REMOVES PLAQUE
  • STRENGHTENS ENAMEL
  • DEEP CLEANS
  • WHITENS
  • FRESHENS BREATH

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:
    • apply toothpaste onto a toothbrush.
    • 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, sodium saccharin, cocamidopropyl betaine

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax COMPLETE PROTECTION

Bleeding, redness, and swelling can be signs of unhealthy gums, eventually weakening the foundation of your teeth.

parodontax Complete Protection builds on the gum health expertise behind our dentist recommended daily fluoride toothpaste – providing 8 benefits designed for healthy gums and strong teeth.

With a fresh minty flavor to enjoy every day.

8 BENEFITS FOR HEALTHY GUMS & STRONG TEETH

Gently whitens

Deep cleans

Helps prevent bleeding gums

Effectively removes plaque

Strengthens and protects enamel

Freshens breath

Works to keep the seal between gums and teeth tight

Reduces red and inflamed gums

Questions Or Comments? (Questions or comments?)

Call toll-free 1-866-844-2797

Principal Display Panel

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

PURE FRESH MINT

COMPLETE PROTECTION

8 BENEFITS

  • REDUCES BLEEDING GUMS
  • REDUCES INFLAMED GUMS
  • GUM SEAL
  • REMOVES PLAQUE
  • STRENGHTENS ENAMEL
  • DEEP CLEANS
  • WHITENS
  • FRESHENS BREATH

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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