Label: AQUAFRESH SENSITIVE MAXIMUM STRENGTH- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0605-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 July 19, 2023

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  • Active ingredients

    Potassium Nitrate (5%)*

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

    *maximum FDA sensitivity active ingredient

  • Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    •
    aids in the prevention of dental cavities.
    •
    builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • Warnings

    When using this product,

    if irritation occurs discontinue use.

    Stop use and ask a dentist if

    •
    the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    •
    pain/sensitivity still persists after 4 weeks of use.

    Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    adults and children 12 years of age and older:
    o
    apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    o
    brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    •
    children under 12 years of age: Consult a dentist or doctor.
  • Other information

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

    water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1

  • Questions or comments?

    Call toll-free 1-800-897-5623

  • Principal Display Panel

    NDC 0135-0605-01

    Aquafresh®

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    triple protection®

    DENTIST RECOMMENDED ACTIVE INGREDIENTS

    maximum strength* sensitive

    Sugar Acid Protection**

    from Fluoride

    •
    healthy gums†
    •
    strong teeth
    •
    fresh breath

    smooth mint

    NET WT 5.6 OZ (158.8 g)

    Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

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

    targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

    †with twice daily brushing

    ALWAYS FOLLOW THE LABEL

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

    GSK Consumer Healthcare Warren, NJ 07059

    *maximum FDA sensitivity active ingredient

    ©2015 GSK or its licensor.

    105481XA

    C:\Users\sh821028\Pictures\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion.
  • INGREDIENTS AND APPEARANCE
    AQUAFRESH  SENSITIVE MAXIMUM STRENGTH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0605
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    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 LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (smooth mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0605-011 in 1 CARTON02/17/2017
    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 not finalpart35602/17/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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