PARODONTAX ACTIVE GUM REPAIR- stannous fluoride paste

parodontax by

Drug Labeling and Warnings

parodontax 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 control bleeding gums.
• 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:
• brush teeth thoroughly, preferably after each meal or 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.
• do not store above 25ºC (77ºF)

Inactive ingredients

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Questions or comments?

1-855-328-5202

Additional information

ALWAYS FOLLOW THE LABEL

Parodontax ACTIVE GUM REPAIR

To keep your gums healthy,
It’s important for the seal between the gum and the teeth to be tight. When plaque bacteria builds up along the gum line, this may loosen the gum seal which leads to gum problems.

New parodontax Active Gum Repairis a daily toothpaste formulated to help reverse early signs of early gum damage by targeting plaque, the main cause of gum problems. The active ingredient kills plaque bacteria at the gum line to help keep the seal tight between gums and teeth and prevent early gum problems.

Kills plaque bacteria at the gum line

For tight gum seal

Healthy gums and teeth

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

©2020 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Principal Display Panel

NDC: 0135-0637-01

NEW

parodontax

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

ACTIVE GUM REPAIR

HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

FRESH MINT

NET WT 3.4 OZ (96.39 g)

1000839

INGREDIENTS AND APPEARANCE

PARODONTAX   ACTIVE GUM REPAIR
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0637
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 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)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
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: 0135-0637-01	1 in 1 CARTON	01/04/2021
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0637-02	1 in 1 CARTON	01/04/2021
2		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)