PARODONTAX- 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 % (0.110 % 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

When using this product,

if irritation occurs discontinue use.

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 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?

Call toll-free 1-855-328-5202

Principal Display Panel

NDC: 0135-0598-01

parodontax

CLEAN MINT

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

Helps prevent bleeding gums

NET WT

3.4 OZ (96.4 g)

PLAQUE BUILDS UP

GUMS SWELL AND BLEED

PARODONTAX HELPS REMOVE PLAQUE

Healthy gums don’t bleed

If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106342XA

Principal Display Panel

NDC: 0135-0599-02

parodontax

EXTRA FRESH

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

Helps prevent bleeding gums

NET WT

3.4 OZ (96.4 g)

PLAQUE BUILDS UP

GUMS SWELL AND BLEED

PARODONTAX HELPS REMOVE PLAQUE

Healthy gums don’t bleed

If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106344XA

Principal Display Panel

NDC: 0135-0601-01

parodontax

WHITENING

DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

Helps prevent bleeding gums

NET WT

3.4 OZ (96.4 g)

PLAQUE BUILDS UP

GUMS SWELL AND BLEED

PARODONTAX HELPS REMOVE PLAQUE

Healthy gums don’t bleed

If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106345XA

INGREDIENTS AND APPEARANCE

PARODONTAX 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0598
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0598-01	1 in 1 CARTON	12/19/2016
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0598-02	1 in 1 CARTON	05/02/2018
2		23 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 not final	part356	12/19/2016

PARODONTAX 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0599
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
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: 0135-0599-01	1 in 1 CARTON	12/19/2016	10/31/2019
1		23 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0599-02	1 in 1 CARTON	12/19/2016
2		96.4 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 not final	part356	12/19/2016

PARODONTAX 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0601
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
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: 0135-0601-01	1 in 1 CARTON	12/19/2016
1		96.4 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 not final	part356	12/19/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)