Parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:00:35

Label at a glance#

ProductParodontax Active Gum Health Daily Mouthwash Breath Freshener
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure11 sections

Indications and uses

helps prevent and reduce plaque that leads to ■ gingivitis, an early form of gum disease ■ bleeding gums

Dosage and administration

■ adults and children 6 years of age and older: 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07% w/w

Purposes

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce plaque that leads to

■ gingivitis, an early form of gum disease

■ bleeding gums

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

■ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions(500 mL)

DOSAGE & ADMINISTRATION SECTION

■ adults and children 6 years of age and older: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

Directions(1000 mL)

DOSAGE & ADMINISTRATION SECTION

■ adults and children 6 years of age and older:vigorously swish 20 milliliters (4 teaspoonfuls) of 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

OTHER SAFETY INFORMATION

■ this product is not intended to replace brushing or flossing

■ may cause staining

■ do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, poloxamer 407, flavor, benzoic acid, sodium benzoate, sucralose, zinc lactate, sodium saccharin, green 3, yellow 6, cinnamal

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional information

SPL UNCLASSIFIED SECTION

parodontax

ACTIVE GUMHEALTH

BREATH FRESHENER

With Breath Cleanse Technology that is designed to kill bacteria that cause bad breath.

ALWAYS FOLLOW THE LABEL
Do not use if printed safety seal around cap is broken or missing.

*Kills plaque bacteria associated with gingivitis in a laboratory test

Distributed by: Haleon,Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or licensor.

Proudly made in the USA with US & globally sourced ingredients. Active made in India.

BOTTLE
RECYCLE

CAP
CHECK LOCALLY†

†Recycling facilities for this product may not exist in your area. Cap film not recyclable.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

HALEON

DENTIST RECOMMENDED

parodontax

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ACTIVE GUMHEALTH

DAILY MOUTHWASH

HELPS PREVENT BLEEDING GUMS

& BAD BREATH BACTERIA

BREATH CLEANSE TECHNOLOGY

BREATH FRESHENER

KILLS 99.9%
PLAQUE BACTERIA*

0% ALCOHOL

NET WT 16.9 FL OZ (500 mL)

216841
L0021380FC

Parodontax Active Gum Health MW BF 500 mL.JPG
Parodontax Active Gum Health MW BF 500 mL.JPG

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0652-02ParodontaxActive Gum Health Daily Mouthwash Breath Freshener500 mL in 1 BOTTLELIQUID5004
0135-0652-03ParodontaxActive Gum Health Daily Mouthwash Breath Freshener1000 mL in 1 BOTTLELIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0652PARODONTAX ACTIVE GUM HEALTH DAILY MOUTHWASH BREATH FRESHENER (CETYLPYRIDINIUM CHLORIDE) LIQUID [HALEON US HOLDINGS LLC]4Current NDC, 2 package rows20250509_32b632bf-058d-447b-a7fb-a9dd05c1e2b8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06520135-0652-02, 0135-0652-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
ndc (package): 0135-0652-03
ndc (package): 0135-0652-02
ndc (product): 0135-0652
ndc11 (package): 00135065202
ndc11 (package): 00135065203
spl id: 349e4c96-3223-bde4-e063-6294a90aef2e
spl set id: 32b632bf-058d-447b-a7fb-a9dd05c1e2b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.