Parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:56

Label at a glance#

ProductParodontax Gum Strengthen and Protect
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)

Purpose

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

SPL UNCLASSIFIED SECTION

  • 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 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, sodium hyaluronate, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

parodontax

GUM STRENGTHEN & PROTECT

Healthy gums form a tight seal around teeth. Reducing plaque bacteria build-up helps to prevent gum problems.

parodontax Gum Strengthen & Protectdaily fluoride toothpaste helps strengthen the gum seal around teeth for long-lasting gum protection.*

With Hyaluronic Acid,this toothpaste delivers foaming action for an elevated brushing experience.

*with continued twice daily use

1 STRENGTHEN

Kills plaque bacteria along the gumline for a stronger and tighter seal between gums and teeth.

2 PROTECT

Helps prevent plaque bacteria build-up to maintain healthy gums every day.*

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PROTECTION

GUM STRENGTHEN & PROTECT

FRESH MINT

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

with HYALURONIC ACID for foaming action

NET WT 3.4 OZ (96.4 g)

Parodontax Gum Strengthen and Protect Fresh Mint 3.4 oz
Parodontax Gum Strengthen and Protect Fresh Mint 3.4 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0655-01ParodontaxGum Strengthen and Protect96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
0135-0655-01ParodontaxGum Strengthen and Protect1 in 1 CARTONPASTE, DENTIFRICE12

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
0135-06550135-0655-01

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 Gum Strengthen and ProtectSTANNOUS FLUORIDEHaleon US Holdings LLC3bb40ceb-841b-4a25-e063-6294a90ab8972025-12-15WarningsExact identifier
ndc (package): 0135-0655-01
ndc (product): 0135-0655
ndc11 (package): 00135065501
spl id: 42f314be-90cb-0204-e063-6394a90a22c3
spl set id: 3bb40ceb-841b-4a25-e063-6294a90ab897

Reported adverse events (FAERS/openFDA)#

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