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Aquafresh Extreme Clean Pure Breath Action

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.15mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0604

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 Facts

Active ingredient

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

Purpose

Anticavity

Use
aids in the prevention of dental cavities.

Warnings

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

AQUAFRESH  EXTREME CLEAN PURE BREATH ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0604
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SODIUM CITRATE, UNSPECIFIED FORM 
SACCHARIN SODIUM 
ZINC CHLORIDE 
FERRIC OXIDE YELLOW 
D&C RED NO. 30 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (fresh mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0604-011 TUBE in 1 CARTON
1158.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on Jun 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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