Aquafresh Paste
FDA Label NDC 0135-0605

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Aquafresh (NDC 0135-0605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (0135-0132), active ingredient (0135-0605), purpose, use (0135-0132), use (0135-0605), when using this product,, stop use and ask a dentist if: (0135-0132), stop use and ask a dentist if (0135-0605), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

      C:\users\sh821028\pictures\105481xa_aquafresh Sensitive Maximum Strength_5_6oz_cartion. (Image 01)

      C:\users\sh821028\pictures\105481xa_aquafresh Sensitive Maximum Strength_5_6oz_cartion. (Image 01)

* Please review the disclaimer below.