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  5. Label Information: Aquafresh Extreme Clean Whitening Action

FDA Label for Aquafresh Extreme Clean Whitening Action

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WHEN USING THIS PRODUCT,
    5. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
    6. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. (WHITENING MULTI ACTION ONLY)
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS (FRESHENING ACTION)
    10. INACTIVE INGREDIENTS (WHITENING ACTION)
    11. INACTIVE INGREDIENTS (DEEP ACTION)
    12. INACTIVE INGREDIENTS (TARTAR CONTROL WHITENING)
    13. INACTIVE INGREDIENTS (ADVANCED 2X ENAMEL)
    14. INACTIVE INGREDIENTS (ADVANCED 2X WHITENING)
    15. INACTIVE INGREDIENTS (ULTIMATE WHITE)
    16. INACTIVE INGREDIENTS (PURE BREATH ACTION)
    17. INACTIVE INGREDIENTS (REVITALIZING ACTION)
    18. INACTIVE INGREDIENTS (CAVITY PROTECTION)
    19. INACTIVE INGREDIENTS (EXTRA FRESH +WHITENING)
    20. INACTIVE INGREDIENTS(WHITENING MULTI ACTION)
    21. QUESTIONS OR COMMENTS?
    22. PRINCIPAL DISPLAY PANEL

Aquafresh Extreme Clean Whitening Action Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium fluoride (0.15% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


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

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

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

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

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

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

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

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

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

      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

          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


* Please review the disclaimer below.