FDA.reportPublic FDA data

parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:28:04

Label at a glance#

Productparodontax Complete Protection
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 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 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 COMPLETE PROTECTION

Bleeding, redness, and swelling can be signs of unhealthy gums, eventually weakening the foundation of your teeth.

parodontax Complete Protection builds on the gum health expertise behind our dentist recommended daily fluoride toothpaste – providing 8 benefits designed for healthy gums and strong teeth.

With a fresh minty flavor to enjoy every day.

8 BENEFITS FOR HEALTHY GUMS & STRONG TEETH

Gently whitens

Deep cleans

Helps prevent bleeding gums

Effectively removes plaque

Strengthens and protects enamel

Freshens breath

Works to keep the seal between gums and teeth tight

Reduces red and inflamed gums

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

WHITENING

COMPLETE PROTECTION

8 BENEFITS

  • REDUCES BLEEDING GUMS
  • REDUCES INFLAMED GUMS
  • GUM SEAL
  • REMOVES PLAQUE
  • STRENGTHENS ENAMEL
  • DEEP CLEANS
  • WHITENS
  • FRESHENS BREATH

NET WT 3.4 OZ (96.4 g)

Parodontax Complete Protection Whitening 3.4 oz
Parodontax Complete Protection Whitening 3.4 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0634-012024-01-30C16284748780-1e4f33bdf-b268-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0634-012023-02-10C16284748780-1e4f33bdf-b268-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0634-012022-07-29C16284748780-1e4f33bdf-b268-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0634-01parodontaxComplete Protection1 in 1 CARTONPASTE17
0135-0634-01parodontaxComplete Protection96.4 g in 1 TUBEPASTE96.47

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
0135-06340135-0634-01

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 Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
ndc (package): 0135-0634-01
ndc (product): 0135-0634
ndc11 (package): 00135063401
spl id: 68c37aad-5ccd-4676-bb15-597383f451e7
spl set id: f6912712-ce9b-44aa-8953-b9a8d420f458

Reported adverse events (FAERS/openFDA)#

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