FDA.reportPublic FDA data

Polident

Manufacturer
Haleon US Holdings LLC
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:25

Label at a glance#

ProductPolident ProPartial
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

aids in the prevention of dental cavities. helps prevent gingivitis, an early form of gum disease. helps interfere with harmful effects of plaque associated with gingivitis.

Dosage and administration

adults and children 2 years of age and older: apply toothpaste onto a toothbrush. brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are establ...

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 prevent gingivitis, an early form of gum disease.
  • 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:
    • apply toothpaste onto a toothbrush.
    • brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • 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.
  • store below 25°C (77°F)

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

1-866-844-2796

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

Your partial can act as a bacteria magnet, attracting more odor-causing bacteria, plaque and debris that if not cleaned can damage your natural teeth.

NEW POLIDENT ProPartialis a simple 3-step range specially developed to cleanse partial dentures, help strengthen teeth, and help protect against odor-causing bacteria.

STEP 1PURIFYYour Partial with Foam Cleanser

STEP 2 STRENGHTENYour Teeth + Gums with Toothpaste

STEP 3 PROTECTYour Teeth with Mouthwash

Strengthens by remineralizing teeth, including vulnerable teeth next to the partial and helps fight plaque bacteria*.

*associated with gingivitis, an early form of gum disease

1-866-844-2796

Distributed by:

GSK Consumer Healthcare,Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2020 GSK group of companies or its licensor.

Made in Germany.

Best used before the end of: see end of carton.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0710-01

POLIDENT

PROPARTIAL

Fluoride Anticavity and Antigingivitis Toothpaste

new

STEP 2 STRENGTHEN TOOTHPASTE FOR TEETH AND GUMS

  • Actively remineralizes teeth + helps fight plaque bacteria*

Net wt 3.4 oz (96.4 g)

62000000050516: Tube

62000000050517: Carton

Polident ProPartial Paste 3.4 oz
Polident ProPartial Paste 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
0135-0710-01PolidentProPartial1 in 1 CARTONPASTE12
0135-0710-01PolidentProPartial96.4 g in 1 TUBEPASTE96.42
0135-0710-02PolidentProPartial65.2 g in 1 TUBEPASTE65.22
0135-0710-02PolidentProPartial1 in 1 CARTONPASTE12
0135-0710-03PolidentProPartial22.7 g in 1 TUBEPASTE22.72
0135-0710-03PolidentProPartial1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0710POLIDENT PROPARTIAL (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 6 package rows20240208_557eeb32-64f4-41e8-ada4-91bd39ae2920.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-07100135-0710-01, 0135-0710-02, 0135-0710-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
ndc (package): 0135-0710-02
ndc (package): 0135-0710-01
ndc (package): 0135-0710-03
ndc (product): 0135-0710
ndc11 (package): 00135071001
ndc11 (package): 00135071003
ndc11 (package): 00135071002
spl id: 10cf4244-39b6-3267-e063-6394a90a7025
spl set id: 557eeb32-64f4-41e8-ada4-91bd39ae2920

Reported adverse events (FAERS/openFDA)#

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