Parodontax Paste, Dentifrice
FDA Label NDC 0135-0655

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Parodontax (NDC 0135-0655). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purpose

Anticavity, Antigingivitis

Uses

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

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.

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.

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

Questions Or Comments?

1-866-844-2797

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.*

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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)

* Please review the disclaimer below.