Aquafresh Paste
FDA Label NDC 0135-0604

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 0135-0604). 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, purpose, use, when using this product,, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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

Purpose

Anticavity

Use

  • aids in the prevention of dental cavities.

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.

    GSK Consumer Healthcare

    Warren, NJ 07059

    1-800-897-5623

    105483XA

* Please review the disclaimer below.