AQUAFRESH  EXTREME CLEAN PURE BREATH ACTION- sodium fluoride paste 
Haleon US Holdings LLC

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Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

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

Other information

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®

†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.

GSKConsumer Healthcare

Warren, NJ 07059

1-800-897-5623

105483XA

105483XA_Aquafresh Extreme Clean pure breath_5.6 oz.JPG
AQUAFRESH   EXTREME CLEAN PURE BREATH ACTION
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0604
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (fresh mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0604-011 in 1 CARTON06/01/2016
1158.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02206/01/2016
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 159951ee-7188-6795-e063-6294a90a314d
Set id: 462eb309-deca-4464-b13a-7ae314e53ede
Version: 5
Effective Time: 20240408
 
Haleon US Holdings LLC