Polident Paste
FDA Label NDC 0135-0710

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Polident (NDC 0135-0710). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purposes

Anticavity, Antigingivitis

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.

Stop Use And Ask A Dentist If

  • 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.

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

Directions

  • 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

  • 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

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium

dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Questions Or Comments?

1-866-844-2796

Additional Information

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

STEP 1PURIFY Your Partial with Foam Cleanser

STEP 2 STRENGHTEN Your Teeth + Gums with Toothpaste

STEP 3 PROTECT Your 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

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 (Image 01)

    Polident Propartial Paste 3.4 Oz (Image 01)

* Please review the disclaimer below.