Label: AQUAFRESH EXTREME CLEAN PURE BREATH ACTION- sodium fluoride paste

  • NDC Code(s): 0135-0604-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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

  • Active ingredient

    Sodium fluoride 0.25% (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 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 of age 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 of age:consult a dentist or doctor.
  • Other information

    • store below 30°C (86°F)
  • Inactive ingredients

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

  • Questions or comments?

    Call toll-free 1-800-897-5623

  • Principal Display Panel

    NDC 0135-0604-01

    Aquafresh ®

    triple protection®

    fluoride toothpaste

    pure breath action

    Sugar Acid Protection**

    from Fluoride

    EXTREME CLEAN ®

    WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

    for 80% cleaner, purer breath*

    NET WT 5.6 OZ (158.8g )

    fresh mint

    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.

    triple protection®

    • healthy gums†
    • strong teeth
    • fresh breath

    †with twice daily brushing

    *immediately after brushing versus a zinc free toothpaste

    ALWAYS FOLLOW THE LABEL

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

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

    GSKConsumer Healthcare

    Warren, NJ 07059

    1-800-897-5623

    105483XA

    105483XA_Aquafresh Extreme Clean pure breath_5.6 oz.JPG
  • INGREDIENTS AND APPEARANCE
    AQUAFRESH   EXTREME CLEAN PURE BREATH ACTION
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0604
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 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)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (fresh mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0604-011 in 1 CARTON06/01/2016
    1158.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/01/2016
    Labeler - Haleon US Holdings LLC (079944263)