FDA Label for Parodontax Active Gum Repair Whitening

View Indications, Usage & Precautions

Parodontax Active Gum Repair Whitening Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Questions Or Comments?



1-855-328-5202


Additional Information



ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR

To keep your gums healthy,
It’s important for the seal between the gum and the teeth to be tight. When plaque bacteria builds up along the gum line, this may loosen the gum seal which leads to gum problems.

New parodontax Active Gum Repair is a daily toothpaste formulated to help reverse early signs of early gum damage by targeting plaque, the main cause of gum problems. The active ingredient kills plaque bacteria at the gum line to help keep the seal tight between gums and teeth and prevent early gum problems.

Kills bacteria to help repair gums

For tight gum seal

Healthy gums and teeth

Trademarks are owned by or licensed to the GSK group of companies.

©2021 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059


Principal Display Panel



NDC 0135-0638-04

NEW

parodontax

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

ACTIVE GUM REPAIR

HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

WHITENING

NET WT 3.4 OZ (96.4 g)

62000000062545 Front Carton


* Please review the disclaimer below.