Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3bb40ceb-841b-4a25-e063-6294a90ab897
Route
DENTAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate Anhydrous Sodium Lauryl Sulfate Polyacrylic Acid (250000 Mw) Cocamidopropyl Betaine Saccharin Sodium Hyaluronate Sodium Basic Blue 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

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.
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 25°C (77°F)
Inactive Ingredients

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, sodium hyaluronate, blue 1

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax

GUM STRENGTHEN & PROTECT

Healthy gums form a tight seal around teeth. Reducing plaque bacteria build-up helps to prevent gum problems.

parodontax Gum Strengthen & Protectdaily fluoride toothpaste helps strengthen the gum seal around teeth for long-lasting gum protection.*

With Hyaluronic Acid,this toothpaste delivers foaming action for an elevated brushing experience.

*with continued twice daily use

1 STRENGTHEN

Kills plaque bacteria along the gumline for a stronger and tighter seal between gums and teeth.

2 PROTECT

Helps prevent plaque bacteria build-up to maintain healthy gums every day.*

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NEW

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PROTECTION

GUM STRENGTHEN & PROTECT

FRESH MINT

HELPS STRENGTHEN THE GUM SEAL AROUND TEETH FOR LONG-LASTING GUM PROTECTION*

with HYALURONIC ACID for foaming action

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.
Purpose

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 25°C (77°F)
Inactive Ingredients (Inactive ingredients)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, sodium hyaluronate, blue 1

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax

GUM STRENGTHEN & PROTECT

Healthy gums form a tight seal around teeth. Reducing plaque bacteria build-up helps to prevent gum problems.

parodontax Gum Strengthen & Protectdaily fluoride toothpaste helps strengthen the gum seal around teeth for long-lasting gum protection.*

With Hyaluronic Acid,this toothpaste delivers foaming action for an elevated brushing experience.

*with continued twice daily use

1 STRENGTHEN

Kills plaque bacteria along the gumline for a stronger and tighter seal between gums and teeth.

2 PROTECT

Helps prevent plaque bacteria build-up to maintain healthy gums every day.*

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

NEW

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PROTECTION

GUM STRENGTHEN & PROTECT

FRESH MINT

HELPS STRENGTHEN THE GUM SEAL AROUND TEETH FOR LONG-LASTING GUM PROTECTION*

with HYALURONIC ACID for foaming action

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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