drug facts

drug facts
SPL v2
SPL
SPL Set ID 557eeb32-64f4-41e8-ada4-91bd39ae2920
Route
dental
Published
Effective Date 2020-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
glycerin polyethylene glycol 400 hydrated silica sodium tripolyphosphate anhydrous sodium lauryl sulfate titanium dioxide cocamidopropyl betaine saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2021-01-04

Purpose

Anticavity, Antigingivitis

Description

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


Medication Information

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.
Purpose

Anticavity, Antigingivitis

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

Description

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

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

Purposes

Anticavity, Antigingivitis

Active Ingredient

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

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 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.

Questions Or Comments?

1-866-844-2796

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.


Structured Label Content

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.
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 (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 (Inactive ingredients)

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

dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

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

Purposes

Anticavity, Antigingivitis

Active Ingredient (Active ingredient)

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

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 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.

Questions Or Comments? (Questions or comments?)

1-866-844-2796

Stop Use and Ask A Dentist If (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. (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.


Advanced Ingredient Data


Raw Label Data

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