FDA.reportPublic FDA data

parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:27:55

Label at a glance#

Productparodontax Active Gum Repair Whitening
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

• aids in the prevention of dental cavities. • helps control bleeding gums. • helps interfere with harmful effects of plaque associated with gingivitis.

Dosage and administration

• adults and children 2 years of age and older: • brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Minimize swallowing. • 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity

Antigingivitis

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • helps interfere with harmful effects of plaque associated with gingivitis.

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Minimize swallowing.
    • 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

OTHER SAFETY 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 25ºC (77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR

Plaque buildup on gums and teeth can lead to gum disease.

parodontax Active Gum Repair is a daily fluoride toothpaste formulated to help reverse signs of early gum disease by targeting plaque, the main cause of gum problems. It is 3xs more effective at removing plaque*

With a fresh minty flavor to enjoy every day.

*vs a sodium monofluorophosphate toothpaste with regular brushing

Targets plaque bacteria

Improves gum health

Fights early gum disease

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

WHITENING

CLINICALLY PROVEN TO HELP REVERSE SIGNS OF EARLY GUM DISEASE:

✓ BLEEDING, ✓ REDNESS, ✓ SWELLING

NET WT 3.4 OZ (96.4 g)

Parodontax Active Gum Repair Whitening 3.4
Parodontax Active Gum Repair Whitening 3.4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN5
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD5
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0638-03parodontaxActive Gum Repair Whitening1 in 1 CARTONPASTE15
0135-0638-03parodontaxActive Gum Repair Whitening65.2 g in 1 TUBEPASTE65.25
0135-0638-04parodontaxActive Gum Repair Whitening1 in 1 CARTONPASTE15
0135-0638-04parodontaxActive Gum Repair Whitening96.4 g in 1 TUBEPASTE96.45
0135-0638-06parodontaxActive Gum Repair Whitening96.4 g in 1 TUBEPASTE96.45
0135-0638-06parodontaxActive Gum Repair Whitening2 in 1 CARTONPASTE25

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06380135-0638-03, 0135-0638-04, 0135-0638-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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 Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
ndc (package): 0135-0638-04
ndc (package): 0135-0638-03
ndc (package): 0135-0638-06
ndc (product): 0135-0638
ndc11 (package): 00135063806
ndc11 (package): 00135063803
ndc11 (package): 00135063804
spl id: 7483472a-9e10-436c-aa9f-abe78b3f2d75
spl set id: 817e804c-e55e-4d77-9ab9-ff54ae794725

Reported adverse events (FAERS/openFDA)#

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