Label: AQUAFRESH EXTREME CLEAN WHITENING ACTION- sodium fluoride paste
AQUAFRESH EXTREME CLEAN DEEP ACTION- sodium fluoride paste

  • NDC Code(s): 0135-0234-06, 0135-0234-08, 0135-0432-02, 0135-0432-05
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 24, 2024

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  • 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 yearsconsult a dentist or doctor
  • Other information

    • store below 30°C (86°F)
  • 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

  • Questions or comments?

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

  • Principal Display Panel

    NDC 0135-0234-08

    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

    TWIN VALUE PACK

    2 TUBES OF 5.6 OZ (158.7g) EACH

    TOTAL NET WT 11.2 OZ (317.4g)

    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! ®

    Sugar Acid Protection**

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

    triple protection

    • healthy gums†
    • strong teeth
    • fresh breath

    †with twice daily brushing

    *vs a regular toothpaste

    ALWAYS FOLLOW THE LABEL

    Trademarks are owned by or licensed to the GSK group of companies.

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

    GSKConsumer Healthcare

    Warren, NJ 07059

    ©2015 GSK group of companies

    1-800-897-5623

    105517XA

    C:\Users\jx336321\Pictures\Drug Listing\105517XA_Aquafresh Extreme Clean Whitening Action 0234_2 x 5.6 oz.JPG
  • 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.

    GlaxoSmithKlineConsumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2015 GSK group of companies

    We value your feedback

    1-800-897-5623

    101883XD

    Aquafresh Extreme Clean Deep Action 5.6 oz carton
  • INGREDIENTS AND APPEARANCE
    AQUAFRESH   EXTREME CLEAN WHITENING ACTION
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0234
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0234-061 in 1 CARTON03/25/2011
    1158.7 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0234-082 in 1 CARTON03/25/2011
    2158.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/25/2011
    AQUAFRESH   EXTREME CLEAN DEEP ACTION
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0432
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0432-021 in 1 CARTON03/25/201107/31/2019
    1158.7 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0432-051 in 1 CARTON03/25/201107/31/2019
    222.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/25/201107/31/2019
    Labeler - Haleon US Holdings LLC (079944263)
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