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  5. Label Information: Aquafresh Extreme Clean Pure Breath Action

FDA Label for Aquafresh Extreme Clean Pure Breath Action

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WHEN USING THIS PRODUCT,
    5. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. PRINCIPAL DISPLAY PANEL

Aquafresh Extreme Clean Pure Breath Action 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



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.