POLIDENT PROPARTIAL- stannous fluoride paste

Polident by

Drug Labeling and Warnings

Polident by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Warnings

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 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

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

INGREDIENTS AND APPEARANCE

POLIDENT   PROPARTIAL
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0710
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0710-01	1 in 1 CARTON	01/04/2021
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0710-02	1 in 1 CARTON	01/04/2021
2		65.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0710-03	1 in 1 CARTON	01/04/2021
3		22.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/04/2021

Labeler - Haleon US Holdings LLC (079944263)