AQUAFRESH TARTAR CONTROL WHITENING- sodium fluoride paste 
AQUAFRESH ULTIMATE WHITE- sodium fluoride paste 
AQUAFRESH EXTREME CLEAN WHITENING ACTION- sodium fluoride paste 
AQUAFRESH EXTREME CLEAN DEEP ACTION- sodium fluoride paste 
AQUAFRESH EXTREME CLEAN FRESHENING ACTION- sodium fluoride paste 
AQUAFRESH WHITE AND SHINE- sodium fluoride paste 
AQUAFRESH ADVANCED 2X ENAMEL- sodium fluoride paste 
AQUAFRESH EXTREME CLEAN POLISHING ACTION- sodium fluoride paste 
AQUAFRESH ADVANCED 2X WHITENING- sodium fluoride paste 
AQUAFRESH PURE BREATH ACTION- sodium fluoride paste 
AQUAFRESH EXTREME CLEAN REVITALIZING ACTION- sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare LP

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.

Directions

adults and children 2 years 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 use as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing 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 (Polishing Action)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, mica, 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 (White & Shine)

sorbitol, water, silica, hydrated silica, PEG-8, sodium lauryl sulfate, flavor, disodium phosphate, xanthan gum, titanium dioxide, sodium saccharin, sodium sulfite, sodium benzoate, mica

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

Questions or comments?

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

Principal Display Panel

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

Aquafresh Extreme Clean Freshing Action carton

Principal Display Panel

Aquafresh®

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION & WHITENING

POLISHING ACTION

POLISHED TEETH STAY CLEANER LONGER*

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 Polishing Action rinses clean and clear, leaving nothing behind but polished, clean, white teeth and has a distinctive energizing 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

30833XA

Aquafresh Extreme Clean Polishing Action carton

Principal Display Panel

NDC 0135-0234-06

Aquafresh®

fluoride toothpaste

triple protection ®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

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*. It’s like a boost of confidence in a tube! Take the Feeling of Clean to the Extreme!®

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

healthy gums

strong teeth

fresh breath

with regular brushing

ALWAYS FOLLOW THE LABEL

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline

Made in the U.S.A.

*Than a regular toothpaste

101895XA

Aquafresh Extreme Clean Whitening Action 5.6 oz carton

Principal Display Panel

NDC 0135-0432-02

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

deep action

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. It’s like a boost of confidence in a tube! Take the Feeling of Clean to the Extreme!®

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

healthy gums

strong teeth

fresh breath

with regular brushing

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.

101883XB

Aquafresh Extreme Clean Deep Action 5.6 oz carton

Principal Display Panel

Aquafresh®

FLUORIDE TOOTHPASTE

TRIPLE PROTECTION®

WHITE & SHINE®

DUAL ACTION

CLEANS AND POLISHES

CLEANS AND POLISHES FOR WHITER, SHINIER TEETH

FRESH MINT

NET WT. 6.0 OZ (170.0g)

A minty fresh, sparkling gel formula that works in two ways to clean and polish. Leaves you with whiter, shinier teeth and icy fresh breath that makes you want to smile.

FIGHTS PLAQUE

HEALTHY GUMS

FRESH BREATH

Not only helps whiten teeth...

also uses micro-buffing particles to actually polish away imperfections...

for that perfect smooth finish.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in England

AQUAFRESH®, TRIPLE PROTECTION®, White & Shine®, and the three striped logo are trademarks of the GlaxoSmithKline group of companies.

www.Aquafresh.com

©2010 GlaxoSmithKline

30719XA

Aquafresh White & Shine carton

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

Aquafresh Tartar Control Whitening 6.0 oz carton

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,

©2012 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.

102142XA

Aquafresh Advanced 2x enamel strengthening action 5.6 oz carton

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

Aquafresh Advanced 2x Whitening 6.0 oz carton

Principal Display Panel

NDC 0135-0201-01

Aquafresh®

fluoride toothpaste

triple protection®

ultimate white

healthy gums

strong teeth

fresh breath

frost mint

NEW WT 6.0oz(170.0g)

Aquafresh® Triple Protection® toothpaste cares for your mouth, helping you keep it healthy and happy. Our toothpaste contains tiny whitening crystals to gently polish your teeth, lift away stains and helps to prevent new stains from reappearing. While you brush, our unique formulation not only strengthens your teeth, but also helps revive their natural whiteness.

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

with regular brushing

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.

102145XA

Aquafresh Ultimate White 6.0 oz carton

Principal Display Panel

NDC 0135-0523-06

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

pure breath action

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.* It’s like a boost of confidence in a tube! Take the Feeling of Clean to the Extreme!®

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

healthy gums

strong teeth

fresh breath

with regular brushing

*immediately after brushing versus a zinc free toothpaste

ALWAYS FOLLOW THE LABEL

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline 

Made in Germany

101864XA

Aquafresh Extreme Clean Pure Breath 5.6 oz carton

Principal Display Panel

NDC 0135-0435-02

Aquafresh®

fluoride toothpaste

triple protection®

EXTREME CLEAN®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

revitalizing action

icy-cool feeling lasts

ice mint

NET WT 5.6 oz (158.7g)

Aquafresh® Extreme Clean® Revitalizing Action toothpaste creates micro-active foam which seeks out all those hard to reach places, in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. Engergize your whole mouth with an icy cool feeling that leaves your mouth revitalized long after you brush. It’s like a boost of confidence in a tube! Take the Feeling of Clean to the Extreme!®

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

healthy gums

strong teeth

fresh breath

with regular brushing

ALWAYS FOLLOW THE LABEL

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline 

Made in the U.S.A.

101585XA

Aquafresh Extreme Clean Revitalizing Action 5.6 oz carton
AQUAFRESH  TARTAR CONTROL WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DIHYDRATE 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0179-031 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  ULTIMATE WHITE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DIHYDRATE 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0201-011 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  EXTREME CLEAN WHITENING ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DIHYDRATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0234-061 in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0234-041 in 1 CARTON
2198.5 g in 1 TUBE
3NDC:0135-0234-071 in 1 CARTON
370.87 g in 1 TUBE
4NDC:0135-0234-021 in 1 CARTON
422.7 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 DRUG LABELItem 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 DIHYDRATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0432-021 in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0432-041 in 1 CARTON
2198.5 g in 1 TUBE
3NDC:0135-0432-051 in 1 CARTON
322.7 g in 1 TUBE
4NDC:0135-0432-011 in 1 CARTON
4121.9 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 DRUG LABELItem 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 DIHYDRATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0435-021 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  WHITE AND SHINE
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0441
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
SORBITOL 
WATER 
SILICON DIOXIDE 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE, DIBASIC 
XANTHAN GUM 
TITANIUM DIOXIDE 
SACCHARIN SODIUM DIHYDRATE 
SODIUM SULFITE 
SODIUM BENZOATE 
MICA 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0441-011 in 1 CARTON
1170.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/201102/28/2013
AQUAFRESH  ADVANCED 2X ENAMEL
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DIHYDRATE 
CARRAGEENAN 
SODIUM HYDROXIDE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0468-021 in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0468-061 in 1 CARTON
270.87 g in 1 TUBE
3NDC:0135-0468-011 in 1 CARTON
3189.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  EXTREME CLEAN POLISHING ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0472
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 
MICA 
SACCHARIN SODIUM DIHYDRATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0472-031 in 1 CARTON
1158.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/201103/26/2011
AQUAFRESH  ADVANCED 2X WHITENING
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DIHYDRATE 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0473-011 in 1 CARTON
1170.0 g in 1 TUBE
2NDC:0135-0473-031 in 1 CARTON
2121.9 g in 1 TUBE
3NDC:0135-0473-042 in 1 CARTON
3170.0 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 DRUG LABELItem 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 DIHYDRATE 
FD&C BLUE NO. 1 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0523-051 in 1 CARTON
122.7 g in 1 TUBE
2NDC:0135-0523-061 in 1 CARTON
2158.7 g in 1 TUBE
3NDC:0135-0523-071 in 1 CARTON
3198.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/25/2011
AQUAFRESH  EXTREME CLEAN REVITALIZING ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0530
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 DIHYDRATE 
D&C RED NO. 30 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0530-061 in 1 CARTON
1158.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/07/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 11/2012
 
GlaxoSmithKline Consumer Healthcare LP