Parodontax Rinse
FDA Label NDC 0135-0654

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 0135-0654). 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

Cetylpyridinium chloride 0.07% w/w

Purposes

Antigingivitis, Antiplaque

Uses

helps prevent and reduce plaque that leads to

  • gingivitis, an early form of gum disease
  • bleeding gums

Stop Use And Ask A Dentist If

  • irritation occurs
  • 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 space 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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adult and children 6 years of age and older:measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from the bottle.
  • children 6 years to under 12 years of age:supervise use
  • children under 6 years of age:do not use

Other Information

  • this rinse is not intended to replace brushing or flossing
  • may cause staining
  • do not store above 25°C (77°F)
  • this product may turn cloudy. Its antimicrobial properties are not affected.

Inactive Ingredients

water, glycerin, propylene glycol, poloxamer 407, flavor, benzoic acid, sodium benzoate, sodium saccharin, sucralose, sodium hyaluronate, blue 1

Questions Or Comments?

1-866-844-2797

Additional Information

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*With continued twice daily use

Principal Display Panel

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

GUM STRENGTHEN & PROTECT

with HYALURONIC ACIDfor extra freshness

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

ICY MINT

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

* Please review the disclaimer below.