PARODONTAX- stannous fluoride paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

106342XA_parodontax_clean mint_3.4 OZ.JPG

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

106344XA_Parodontax_Extra Fresh_3.4 OZ.JPG

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

106345XA_parodontax_whitening_3.4 OZ.JPG
PARODONTAX 
stannous fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0598
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0598-011 in 1 CARTON12/19/2016
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0598-021 in 1 CARTON05/02/2018
223 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/19/2016
PARODONTAX 
stannous fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0599
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0599-011 in 1 CARTON12/19/201610/31/2019
123 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0599-021 in 1 CARTON12/19/2016
296.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/19/2016
PARODONTAX 
stannous fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0601
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0601-011 in 1 CARTON12/19/2016
196.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/19/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2020
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC