Parodontax Paste
FDA Label NDC 0135-0737

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 0135-0737). 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, purposes, 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)

Purposes

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, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • 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, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, zinc chloride, carrageenan

Questions Or Comments?

1-855-328-5202

Additional Information

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR
Bleeding gums and bad breath can be a sign of early gum problems.

New parodontax Active Gum Repair Breath Freshener is a daily toothpaste that helps reverse signs of early gum damage and uses Breath Cleanse Technology* to purify bad breath instead of just masking it.

  • It is specially formulated to kill plaque bacteria at the gumline to help

    keep the gum seal tight and prevent early gum problems.

  • Its Breath Cleanse Technology* utilizes zinc, an antibacterial ingredient

    scientifically proven to purify gases that cause bad breath.

    • *compared to parodontax Clean Mint toothpaste

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059 Made in Germany

    Trademarks owned or licensed by GSK. ©2023 GSK or licensor.

Principal Display Panel

NEW

parodontax

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

ACTIVE GUM REPAIR

HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

BREATH FRESHENER

BREATH CLEANSE TECHNOLOGY*

NET WT 3.4 OZ (96.4 g)

62000000203673 – Front Carton

* Please review the disclaimer below.