FDA Label for Aquafresh Sensitive Maximum Strength

View Indications, Usage & Precautions

Aquafresh Sensitive Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (0135-0132)



Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)


Active Ingredient (0135-0605)



Potassium nitrate (5%)

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


Purpose



Antihypersensitivity

Anticavity


Use (0135-0132)



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

Use (0135-0605)



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

When Using This Product,



if irritation occurs discontinue use.


Stop Use And Ask A Dentist If: (0135-0132)



  • •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


Stop Use And Ask A Dentist If (0135-0605)



  • •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 (0135-0132)



  • adults and children 12 years of age and older:
    • • apply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • •brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and no 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

Directions (0135-0605)



  • adults and children 12 years of age and older:
    • • apply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • •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 (0135-0132)



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


Inactive Ingredients (0135-0605)



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? (0135-0132)



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


Questions Or Comments? (0135-0605)



Call toll-free 1-800-897-5623


Principal Display Panel



NDC 0135-0132-03

Aquafresh®

fluoride toothpaste for sensitive teeth

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength*

sensitive

Sugar Acid Protection**

  • healthy gums†
  • strong teeth
  • fresh breath
  • From Fluoride

    smooth mint

    NET WT 5.6 OZ (158.7g)

    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

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

    †with twice daily brushing

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2015 GSK

    ALWAYS FOLLOW THE LABEL

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

    *maximum FDA sensitivity active ingredient

    103265XC

    NDC 0135-0605-01

    Aquafresh®

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    triple protection®

    DENTIST RECOMMENDED ACTIVE INGREDIENTS

    maximum strength* sensitive

    Sugar Acid Protection**

    • healthy gums†
    • strong teeth
    • fresh breath
    • from Fluoride

      smooth mint

      NET WT 5.6 OZ (158.8g)

      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


* Please review the disclaimer below.