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AQUAFRESH TARTAR CONTROL WHITENING

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.10mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0179

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.

Drug Facts

Active ingredient

Sodium fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

When using this product,

if irritation occurs discontinue use

Keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age. (Whitening Multi Action only)

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 and older:
apply toothpaste onto a toothbrush 
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 consult a dentist or doctor

Other information
store below 30°C (86°F)

Inactive ingredients (Freshening Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, titanium dioxide, sodium saccharin, synthetic iron oxide, D&C red #30

Inactive ingredients (whitening action)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30

Inactive ingredients (deep action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Inactive ingredients (tartar control whitening)

water, hydrated silica, sorbitol, glycerin, tetrapotassium pyrophosphate, PEG-8, tetrasodium pyrophosphate, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium saccharin, sodium benzoate, blue 1 lake, red 30 lake

Inactive ingredients (advanced 2x enamel)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, carbomer, sodium saccharin, carrageenan gum, sodium hydroxide, blue 1 lake, red 30

Inactive ingredients (advanced 2x whitening)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, sodium hydroxide, sodium saccharin, sodium benzoate, blue 1 lake, red 30 lake

Inactive ingredients (ultimate white)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, sodium hydroxide, sodium saccharin, sodium benzoate, blue 1 lake, red 30 lake

Inactive ingredients (Pure Breath Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium citrate, zinc chloride, sodium saccharin, blue 1, iron oxides, red 30

Inactive ingredients (Revitalizing Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Inactive ingredients (Cavity Protection)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, polyethylene, red 30, blue 1 lake

Inactive ingredients (Extra Fresh +Whitening)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, polyethylene, red 30, blue 1 lake

Inactive Ingredients(Whitening Multi Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, polyethylene, red 30, blue 1 lake

Questions or comments?

call toll-free 1-800-897-5623 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0435-02

Aquafresh®

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION & WHITENING

FRESHENING ACTION

FIGHTS SOURCES OF BAD BREATH

Healthy Gums

Strong Teeth

Fresh Breath

NET WT 5.6 oz (158.7g)

TAKE THE FEELING OF CLEAN TO THE EXTREME!®

With all the Triple Protection of Aquafresh, Extreme Clean's dynamic Micro-Active Foam showers your whole mouth with germ killing bubbles, helps to protect teeth with fluoride, and helps to maintain healthy gums with regular brushing.

Our professionally developed micro polishing system carefully polishes teeth smooth making them stay cleaner & whiter for longer* and seeks out hard to reach places - in between teeth & even the back of your tongue - fighting the sources of bad breath.

Aquafresh Extreme Clean Freshening Action rinses clean and clear, leaving nothing behind but polished, clean, white teeth and has a distinctive refreshing mint flavor that leaves an icy cool, sparkling feeling long after you brush.

*Scientific testing shows that after only one tube you'll be left with significantly cleaner, smoother teeth than with a regular toothpaste!

AQUAFRESH®, EXTREME CLEAN®, TAKE THE FEELING OF CLEAN TO THE EXTREME!®, TRIPLE PROTECTION®, and the three striped logo are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2009 GlaxoSmithKline

Experience it online at www.Aquafresh.com

30835XA

Principal Display Panel

NDC 0135-0234-06

Aquafresh®

fluoride toothpaste

triple protection ®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

Sugar Acid Protection**

from Fluoride

mint blast

helps restore natural whiteness

NET WT 5.6 oz (158.7g)

Aquafresh® Extreme Clean® Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme!®

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

healthy gums†

strong teeth

fresh breath

†with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies

We value your feedback

1-800-897-5623

*Than a regular toothpaste

101895XC

Principal Display Panel

NDC 0135-0432-02

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

deep action

Sugar Acid Protection**

from Fluoride

mint zest

for a whole mouth clean

NET WT 5.6 oz (158.7g)

Aquafresh® Extreme Clean® Deep Action toothpaste creates micro-active foam which seeks hard to reach places; in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. Enjoy a whole mouth clean. Take the Feeling of Clean to the Extreme!®

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

healthy gums*

strong teeth

fresh breath

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies

We value your feedback

1-800-897-5623

101883XD

Principal Display Panel

NDC 0135-0179-03

Aquafresh®

fluoride toothpaste

triple protection®

tartar control + whitening

healthy gums

strong teeth

fresh breath

clean mint

NET WT 6.0 OZ (170.0g)

Aquafresh® Triple Protection® toothpaste cares for your mouth, helping you keep it healthy and happy. Our Tartar Control + Whitening toothpaste helps prevent new tartar buildup above the gum line while gentle whiteners remove stains.

For lots of reasons to smile visit www.Aquafresh.com

with regular brushing

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

101926XA

Principal Display Panel

NDC 0135-0468-02

Aquafresh®

fluoride toothpaste

triple protection®

advanced

2x enamel strengthening action*

deep strengthening formula

fresh mint

DENTIST RECOMMENDED ACTIVE INGREDIENT

NET WT 5.6oz(158.7g)

Aquafresh® Advanced toothpaste cares for your mouth, helping you keep it healthy and happy. While you brush, our Advanced 2x Enamel Strengthening Action* toothpaste helps lock in vital minerals and lock out plaque acids for clean, strong, healthy teeth.

For lots of reasons to smile visit www.Aquafresh.com

healthy gums

strong teeth

fresh breath

with regular brushing

*in laboratory tests versus regular Aquafresh® toothpaste

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108,

©2013 GlaxoSmithKline 

Made in Taiwan

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

102142XB

Principal Display Panel

NDC 0135-0473-01

Aquafresh®

fluoride toothpaste

triple protection®

advanced

2x whitening*

stain removing formula

ice mint

DENTIST RECOMMENDED ACTIVE INGREDIENT

NET WT 6.0oz(170.0g)

Aquafresh® Advanced Whitening® toothpaste cares for your mouth, helping you keep it healthy and happy. Our Advanced 2x Whitening toothpaste not only helps strengthen your teeth, but also helps you revive their natural whiteness. Our special formula contains a combination of cleaning agents for two times better whitening*.

For lots of reasons to smile visit www.Aquafresh.com

healthy gums

strong teeth

fresh breath

with regular brushing

*in laboratory tests versus Aquafresh® 2x Enamel Strengthening Action toothpaste

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline 

Made in the U.S.A.

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

102139XA

Principal Display Panel

NDC 0135-0201-01

Aquafresh®

fluoride toothpaste

triple protection®

ultimate white

Sugar Acid Protection**

from Fluoride

with enhanced whitening action*

frost mint

NEW WT 6.0oz(170.0g)

Aquafresh® Ultimate White toothpaste contains tiny whitening crystals to gently polish your teeth, lift away stains and helps to prevent new stains from appearing.

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

healthy gums†

strong teeth

fresh breath

†with twice daily brushing

*as compared to a standard toothpaste

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK

103114XB

Principal Display Panel

NDC 0135-0523-06

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

pure breath action

Sugar Acid Protection**

from Fluoride

for 80% cleaner, purer breath*

fresh mint

NET WT 5.6 oz (158.7g)

Aquafresh® Extreme Clean® Pure Breath Action toothpaste creates micro-active foam which seeks out hard-to-reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme!®

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

healthy gums†

strong teeth

fresh breath

†with twice daily brushing

*immediately after brushing versus a zinc free toothpaste

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK

We value your feedback

1-800-897-5623

101864XD

Principal Display Panel

NDC 0135-0563-06

 
Aquafresh®

triple protection®

fluoride toothpaste

healthy gums*
strong teeth
fresh breath

NET WT 5.6 OZ (158.7 g)

cavity protection

Sugar Acid Protection**

from Fluoride

cool mint

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK

Made in Taiwan

We value your feedback

1-800-897-5623

103857XB

Principal Display Panel

NDC 0135-0564-06

 
Aquafresh®

fluoride toothpaste

triple protection®

healthy gums*
strong teeth
fresh breath

extra fresh +whitening

Sugar Acid Protection**

from Fluoride

fresh mint

NET WT 5.6 OZ (158.7 g)

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK

We value your feedback

1-800-897-5623

103863XB

Principal Display Panel

NDC 0135-0586-01

 
Aquafresh®

fluoride toothpaste

triple protection®

NEW

WHITENING MULTI ACTION

Sugar Acid Protection**

from Fluoride

NET WT 5.6 OZ (158.7 g)

cavity protection

healthy gums*

breath

great taste

whitening†

enamel

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

†whitens by removing surface stains

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION and the iconic Nurdle device are trademarks owned by or licensed to the GSK group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies or its licensor. All rights reserved.

104872XA

AQUAFRESH  TARTAR CONTROL WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0179
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POTASSIUM PYROPHOSPHATE 
POLYETHYLENE GLYCOL 400 
SODIUM PYROPHOSPHATE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
XANTHAN GUM 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0179-031 TUBE in 1 CARTON
1170.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/201106/30/2016
AQUAFRESH  ULTIMATE WHITE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0201
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0201-011 TUBE in 1 CARTON
1170.0 g in 1 TUBE
2NDC:0135-0201-031 TUBE in 1 CARTON
2281.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  EXTREME CLEAN WHITENING ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0234
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SACCHARIN SODIUM 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0234-021 TUBE in 1 CARTON
122.7 g in 1 TUBE
2NDC:0135-0234-041 TUBE in 1 CARTON
2198.5 g in 1 TUBE
3NDC:0135-0234-061 TUBE in 1 CARTON
3158.7 g in 1 TUBE
4NDC:0135-0234-082 TUBE in 1 CARTON
4158.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  EXTREME CLEAN DEEP ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0432
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0432-021 TUBE in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0432-051 TUBE in 1 CARTON
222.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  EXTREME CLEAN FRESHENING ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0435
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0435-021 TUBE in 1 CARTON
1158.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  ADVANCED 2X ENAMEL
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0468
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
CARRAGEENAN 
SODIUM HYDROXIDE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0468-011 TUBE in 1 CARTON
1189.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  ADVANCED 2X WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0473
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0473-042 TUBE in 1 CARTON
1170.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  PURE BREATH ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0523
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SODIUM CITRATE 
ZINC CHLORIDE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0523-061 TUBE in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0523-071 TUBE in 1 CARTON
2198.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  CAVITY PROTECTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0563
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
CARRAGEENAN 
D&C RED NO. 30 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (cool mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0563-031 TUBE in 1 CARTON
185 g in 1 TUBE
2NDC:0135-0563-061 TUBE in 1 CARTON
2158.7 g in 1 TUBE
3NDC:0135-0563-071 TUBE in 1 CARTON
3198.5 g in 1 TUBE
4NDC:0135-0563-092 TUBE in 1 CARTON
4158.7 g in 1 TUBE
5NDC:0135-0563-104 TUBE in 1 CARTON
5212.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/09/2014
AQUAFRESH  EXTRA FRESH PLUS WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0564
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
CARRAGEENAN 
D&C RED NO. 30 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (fresh mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0564-031 TUBE in 1 CARTON
185 g in 1 TUBE
2NDC:0135-0564-061 TUBE in 1 CARTON
2158.7 g in 1 TUBE
3NDC:0135-0564-071 TUBE in 1 CARTON
3198.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/09/2014
AQUAFRESH  WHITENING MULTI ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0586
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0586-011 TUBE in 1 CARTON
1158.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/16/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 09/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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