Label: AQUAFRESH CAVITY PROTECTION- sodium fluoride paste
AQUAFRESH EXTRA FRESH PLUS WHITENING- sodium fluoride paste
AQUAFRESH MULTI ACTION WHITENING- sodium fluoride paste
AQUAFRESH ULTIMATE WHITE- sodium fluoride paste

  • NDC Code(s): 0135-0590-01, 0135-0590-02, 0135-0590-04, 0135-0591-01, view more
    0135-0591-02, 0135-0592-01, 0135-0594-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • Active ingredient (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening)

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • Active ingredient (ultimate white)

    Sodium fluoride 0.24% (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 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 (Cavity Protection)

    water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

  • Inactive ingredients (Extra Fresh +Whitening)

    water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

  • Inactive ingredients (Multi Action Whitening)

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

  • Inactive ingredients (ultimate white)

    water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1

  • Questions or comments?

    Call toll-free 1-800-897-5623

  • Principal Display Panel

    NDC 0135-0590-01

     
    Aquafresh®

    fluoride toothpaste

    triple protection®

    •
    healthy gums*
    •
    strong teeth
    •
    fresh breath

    cavity protection

    Sugar Acid Protection**

    from Fluoride

    cool mint

    NET WT 5.6 OZ (158.8 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

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

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    Made in Taiwan

    1-800-897-5623

    105263XA

    Aquafresh Cavity Protection 5.6oz (158.8g) carton
  • Principal Display Panel

    NDC 0135-0591-01

     
    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 (158.8 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

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

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    1-800-897-5623

    105282XA

    Aquafresh Extra Fresh plus Whitening 5.6oz (158.8g) carton
  • Principal Display Panel

    NDC 0135-0594-01

     
    Aquafresh®

    fluoride toothpaste

    triple protection®

    WHITENING

    MULTI ACTION

    Sugar Acid Protection**

    from Fluoride

    NET WT 5.6 OZ (158.8 g)

    cavity protection

    healthy gums*

    breath

    great taste

    whitening†

    enamel

    Invigorating Mint

    cavity protection

    healthy gums*

    fresh breath

    great taste

    removes surface stains

    enamel strengthening

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

    *with twice daily brushing

    †whitens by removing surface stains

    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.

    GSK Consumer Healthcare

    Warren, NJ 07059

    105384XA

    Aquafresh Multi Action Whitening 5.0 oz (158.8g) carton
  • Principal Display Panel

    NDC 0135-0592-01

     
    Aquafresh®

    fluoride toothpaste

    triple protection®

    ultimate white

    Sugar Acid Protection**

    from Fluoride

    with whitening action

    frost mint

    NET WT6.0 OZ (170.1 g)

     
    Aquafresh® Ultimate White toothpaste gently polishes your teeth, lifts away stains and helps to prevent new stains appearing.
     
    **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attach.
    •
    healthy gums†
    •
    strong teeth
    •
    fresh breath
     
    †with twice daily brushing

    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.

    GSK Consumer Healthcare, Warren, NJ 07059

    1-800-897-5623

    105287XA

    Aquafresh ultimate white 6.0 oz (170.1 g) carton
  • INGREDIENTS AND APPEARANCE
    AQUAFRESH  CAVITY PROTECTION
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0590
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (cool mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0590-011 in 1 CARTON10/01/2016
    1158.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0590-042 in 1 CARTON11/01/2016
    2158.8 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0590-021 in 1 CARTON11/01/2016
    385 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/01/2016
    AQUAFRESH  EXTRA FRESH PLUS WHITENING
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0591
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    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:0135-0591-011 in 1 CARTON10/01/2016
    1158.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0591-021 in 1 CARTON11/01/2016
    285.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/09/2014
    AQUAFRESH  MULTI ACTION WHITENING
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0594
    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)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0594-011 in 1 CARTON01/31/201706/30/2018
    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 DrugM02201/31/201706/30/2018
    AQUAFRESH  ULTIMATE WHITE
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0592
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0592-011 in 1 CARTON01/31/201708/31/2020
    1170.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/31/201708/31/2020
    Labeler - Haleon US Holdings LLC (079944263)
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