Parodontax Mouthwash
FDA Label NDC 0135-0650

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 0135-0650). 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 (mint), 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

Purpose

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

Directions

  • adults 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 bottle.
  • children 6 years to under 12 years of age: supervisor 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 or 77°F

Inactive Ingredients (Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Inactive Ingredients (Clear Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid

Questions Or Comments?

1-855-328-5202

Additional Information

*Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory test

Do not use if the printed seal on the cap

is broken or missing.

ALWAYS FOLLOW THE LABEL

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned by or licensed by GSK.

©2021 GSK or licensor.

1-855-328-5202

Principal Display Panel

NDC 0135-0651-02

NEW

parodontax

CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE

ACTIVE GUM HEALTH
DAILY MOUTHWASH

TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD

MINT

KILLS 99.9%
PLAQUE
BACTERIA*

16.9 FL OZ (500 mL)

L0020006FA: Front Label

L0020006BA: Back Label

Parodontax Active Gum Health Mouthwash Mint (Image 01)

Parodontax Active Gum Health Mouthwash Mint (Image 01)

NDC 0135-0650-01

NEW

parodontax

CETYLPYRIDINIUM CHLORIDE ANTIGINGIVITIS/
ANTIPLAQUE MOUTHRINSE

ACTIVE GUM HEALTH

DAILY MOUTHWASH

TARGETS BACTERIA*
& FORMS AN
ANTIBACTERIAL SHIELD

CLEAR MINT

DYE FREE
ALCOHOL FREE

16.9 FL OZ (500 mL)

L0020007FA: Front Label

L0020007BA: Back Label

Parodontax Active Gum Health Mouthwash Clear Mint (Image 02)

Parodontax Active Gum Health Mouthwash Clear Mint (Image 02)

* Please review the disclaimer below.