Label: AQUAFRESH ISO-ACTIVE- sodium fluoride gel 

  • Label RSS
  • NDC Code(s): 0135-0504-01, 0135-0505-01, 0135-0506-01, 0135-0524-01
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Sodium fluoride

    (0.15% w/v fluoride ion)

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  • Purpose

    Anticavity

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  • Use

    aids in the prevention of dental cavities

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  • 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.

    Flammable. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120oF. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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  • Directions

    adults and children 2 years of age and older:
    apply toothgel 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 and rinsing until good habits are established
    children under 2 years of age: consult a dentist or doctor
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  • Inactive ingredients (Fresh Impact)

    water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, blue 1

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  • Inactive ingredients (Deep Impact)

    water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, blue 1, yellow 10

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  • Inactive ingredients (Lasting Impact)

    water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, FD&C blue #1, D&C yellow #10

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  • Inactive ingredients (Pure Breath)

    water, hydrated silica, glycerin, sorbitol, PEG-8, sodium citrate, sodium lauryl sulfate, isopentane, flavor, carrageenan, xanthan gum, zinc chloride, sodium saccharin, citric acid, blue 1

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  • Questions or comments?

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

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  • Principal Display Panel

    NDC 0135-0505-01

    Aquafresh®

    triple protection®

    fluoride toothgel

    iso-active®

    FOAMING GEL

    fresh impact®

    +whitening

    healthy gums

    strong teeth

    fresh breath

    NET WT 4.3 oz (121.6g)

    triple protection®

    strong healthy teeth for a lifetime

    To clean, wipe nozzle without water. Do not remove nozzle

    healthy gums

    strong teeth

    fresh breath

    with regular brushing

    Aquafresh iso-active® Whitening Deep Impact® toothgel is a distinctive refreshing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth

    ALWAYS FOLLOW THE LABEL.

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

    Best before: see base of can.

    RECYCLING INFORMATION:

    Please recycle – when empty.

    Does not contain CFCs.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Taiwan

    www.Aquafresh.com

    ©2012 GlaxoSmithKline

    102150XA

    Aquafresh IsoActive Whitening Fresh Impact 4.3 oz label
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  • Principal Display Panel

    NDC 0135-0504-01

    Aquafresh®

    triple protection®

    fluoride toothgel

    iso-active®

    FOAMING GEL

    deep impact®

    +whitening

    healthy gums

    strong teeth

    fresh breath

    NET WT 4.3 oz (121.6g)

    triple protection®

    strong healthy teeth for a lifetime

    To clean, wipe nozzle without water. Do not remove nozzle

    healthy gums

    strong teeth

    fresh breath

    with regular brushing

    Aquafresh iso-active® Whitening Deep Impact® toothgel is a distinctive flavor invigorating experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth

    ALWAYS FOLLOW THE LABEL.

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

    Best before: see base of can.

    RECYCLING INFORMATION:

    Please recycle – when empty.

    Does not contain CFCs.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Taiwan

    www.Aquafresh.com

    ©2012 GlaxoSmithKline

    102149XA

    Aquafresh IsoActive Whitening Deep Impact 4.3 oz label
    Close
  • Principal Display Panel Lasting Impact

    NDC 0135-0506-01

    Aquafresh®

    FLUORIDE TOOTHGEL

    iso-active®

    WHITENING

    FOAMING GEL

    LASTING IMPACTTM

    TRIPLE PROTECTION®

    HEALTHY GUMS

    STRONG TEETH

    FRESH BREATH

    NET WT 4.3 oz (121.6g)

    For best results, wipe nozzle before and after each use.

    AQUAFRESH® TOOTHPASTE WITH TRIPLE PROTECTION® BENEFITS

    HEALTHY GUMS STRONG TEETH FRESH BREATH

    Aquafresh iso-active® Whitening Lasting ImpactTM, a distinctive energizing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected white teeth while also helping to maintain healthy gums.

    Aquafresh®, iso-active®, Lasting ImpactTMand the three striped logo are trademarks of the GlaxoSmithKline group of companies.

    Best before: see base of can.

    RECYCLING INFORMATION:

    Please recycle – when empty.

    Does not contain CFCs.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Taiwan

    www.Aquafresh.com

    ©2010 GlaxoSmithKline

    53996XC

    Aquafresh Lasting Impact Label
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  • Principal Display Panel Pure Breath Action

    NDC 0135-0524-01

    Aquafresh®

    FLUORIDE TOOTHGEL

    TRIPLE PROTECTION®

    iso-active®

    FOAMING GEL

    EXTREME CLEAN®

    WITH MICRO-ACTIVE FOAMING ACTION & WHITENING

    PURE BREATH ACTION

    STRONG, HEALTHY TEETH FOR A LIFETIME

    NET WT 4.3 oz (121.6g)

    To clean, wipe nozzle without water. Do not remove nozzle.

    AQUAFRESH® TOOTHPASTE WITH TRIPLE PROTECTION® BENEFITS

    HEALTHY GUMS

    STRONG TEETH

    FRESH BREATH

    TAKE THE FEELING OF CLEAN TO THE EXTREME®

    Aquafresh® Extreme Clean® Pure Breath Action iso-active® is a unique gel that transforms into an active foam to penetrate hard to reach places in your mouth. Aquafresh® Extreme Clean® Pure Breath Action for a thorough clean.

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

    Best before: see base of can.

    RECYCLING INFORMATION: Please recycle - when empty.

    Does not contain CFCs.

    DOT-2P

    M5706

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Germany

    www.Aquafresh.com

    ©2011 GlaxoSmithKline

    101041XB

    Aquafresh IsoActive Pure Breath Extreme Clean 4.3 oz label
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  • INGREDIENTS AND APPEARANCE
    AQUAFRESH  ISO-ACTIVE
    sodium fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0505
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    GLYCERIN  
    HYDRATED SILICA  
    SODIUM TRIPOLYPHOSPHATE  
    PEG-8 LAURATE  
    SODIUM LAURYL SULFATE  
    ISOPENTANE  
    CARRAGEENAN  
    XANTHAN GUM  
    COCAMIDOPROPYL BETAINE  
    SODIUM HYDROXIDE  
    SACCHARIN SODIUM  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color GREEN (greenish blue) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0505-01 121.6 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2009
    AQUAFRESH  ISO-ACTIVE
    sodium fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0504
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    GLYCERIN  
    HYDRATED SILICA  
    SODIUM TRIPOLYPHOSPHATE  
    PEG-8 LAURATE  
    SODIUM LAURYL SULFATE  
    ISOPENTANE  
    CARRAGEENAN  
    XANTHAN GUM  
    COCAMIDOPROPYL BETAINE  
    SODIUM HYDROXIDE  
    SACCHARIN SODIUM  
    SUCRALOSE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color GREEN (greenish blue) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0504-01 121.6 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2009
    AQUAFRESH  ISO-ACTIVE
    sodium fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0506
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    GLYCERIN  
    HYDRATED SILICA  
    SODIUM TRIPOLYPHOSPHATE  
    PEG-8 LAURATE  
    SODIUM LAURYL SULFATE  
    ISOPENTANE  
    CARRAGEENAN  
    XANTHAN GUM  
    COCAMIDOPROPYL BETAINE  
    SODIUM HYDROXIDE  
    SACCHARIN SODIUM  
    SUCRALOSE  
    FD&C BLUE NO. 1  
    D&C YELLOW NO. 10  
    Product Characteristics
    Color GREEN (greenish blue) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0506-01 121.6 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2009
    AQUAFRESH  ISO-ACTIVE
    sodium fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0524
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    HYDRATED SILICA  
    GLYCERIN  
    SORBITOL  
    POLYETHYLENE GLYCOL 400  
    SODIUM CITRATE  
    SODIUM LAURYL SULFATE  
    ISOPENTANE  
    CARRAGEENAN  
    XANTHAN GUM  
    ZINC CHLORIDE  
    SACCHARIN SODIUM  
    CITRIC ACID MONOHYDRATE  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0524-01 121.6 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/18/2011
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
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