Pill Identifier App

AQUAFRESH iso-active

Dosage form: gel
Ingredients: SODIUM FLUORIDE 1.5mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0505

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

(0.15% 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 you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Flammable. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120oF. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions
adults and children 2 years of age and older:
apply toothgel onto a toothbrush
brush teeth thoroughly, preferably after each meal, at least twice a day, and not more than 3 times a day, or use as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
to minimize swallowing for children under 6, 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

Inactive ingredients (Fresh Impact)

water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, blue 1

Inactive ingredients (Deep Impact)

water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, blue 1, yellow 10

Inactive ingredients (Lasting Impact)

water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, FD&C blue #1, D&C yellow #10

Inactive ingredients (Pure Breath)

water, hydrated silica, glycerin, sorbitol, PEG-8, sodium citrate, sodium lauryl sulfate, isopentane, flavor, carrageenan, xanthan gum, zinc chloride, sodium saccharin, citric acid, blue 1

Questions or comments?

call toll-free 1-800-897-5623 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0505-01

Aquafresh®

triple protection®

fluoride toothgel

iso-active®

FOAMING GEL

fresh impact®

+whitening

healthy gums

strong teeth

fresh breath

NET WT 4.3 oz (121.6g)

triple protection®

strong healthy teeth for a lifetime

To clean, wipe nozzle without water. Do not remove nozzle

healthy gums

strong teeth

fresh breath

with regular brushing

Aquafresh iso-active® Whitening Deep Impact® toothgel is a distinctive refreshing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth

ALWAYS FOLLOW THE LABEL.

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle – when empty.

Does not contain CFCs.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Taiwan

www.Aquafresh.com

©2012 GlaxoSmithKline

102150XA

Principal Display Panel

NDC 0135-0504-01

Aquafresh®

triple protection®

fluoride toothgel

iso-active®

FOAMING GEL

deep impact®

+whitening

healthy gums

strong teeth

fresh breath

NET WT 4.3 oz (121.6g)

triple protection®

strong healthy teeth for a lifetime

To clean, wipe nozzle without water. Do not remove nozzle

healthy gums

strong teeth

fresh breath

with regular brushing

Aquafresh iso-active® Whitening Deep Impact® toothgel is a distinctive flavor invigorating experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth

ALWAYS FOLLOW THE LABEL.

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle – when empty.

Does not contain CFCs.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Taiwan

www.Aquafresh.com

©2012 GlaxoSmithKline

102149XA

Principal Display Panel Lasting Impact

NDC 0135-0506-01

Aquafresh®

FLUORIDE TOOTHGEL

iso-active®

WHITENING

FOAMING GEL

LASTING IMPACTTM

TRIPLE PROTECTION®

HEALTHY GUMS

STRONG TEETH

FRESH BREATH

NET WT 4.3 oz (121.6g)

For best results, wipe nozzle before and after each use.

AQUAFRESH® TOOTHPASTE WITH TRIPLE PROTECTION® BENEFITS

HEALTHY GUMS STRONG TEETH FRESH BREATH

Aquafresh iso-active® Whitening Lasting ImpactTM, a distinctive energizing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected white teeth while also helping to maintain healthy gums.

Aquafresh®, iso-active®, Lasting ImpactTMand the three striped logo are trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle – when empty.

Does not contain CFCs.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Taiwan

www.Aquafresh.com

©2010 GlaxoSmithKline

53996XC

Principal Display Panel Pure Breath Action

NDC 0135-0524-01

Aquafresh®

fluoride toothgel

triple protection®

iso-active®

FOAMING GEL

EXTREME CLEAN

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

*Immediately after brushing versus a zinc free toothpaste

pure breath action

for 80% cleaner, purer breath*

strong healthy teeth for a lifetime

fresh mint

NET WT 4.3 OZ (121.6g)

To clean, wipe nozzle without water. Do not remove nozzle.

triple protection®

healthy gums

strong teeth

fresh breath

with regular brushing

Aquafresh® Extreme Clean® Pure Breath Action iso-active® toothgel transforms into a micro-active foam to get to hard to reach places in your mouth. As you brush, the unique mineral containing formula neutralizes bad breath odors for 80% cleaner, purer breath*. Take the Feeling of Clean to the Extreme!®

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION: Please recycle - when empty.

Does not contain CFCs.

DOT-2P

M5706

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Germany

www.Aquafresh.com

©2012 GlaxoSmithKline

102151XA

AQUAFRESH  ISO-ACTIVE
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0505
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
GLYCERIN 
HYDRATED SILICA 
SODIUM TRIPOLYPHOSPHATE 
PEG-8 LAURATE 
SODIUM LAURYL SULFATE 
ISOPENTANE 
CARRAGEENAN 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREEN (greenish blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0505-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/200901/31/2015
AQUAFRESH  ISO-ACTIVE
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0504
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
GLYCERIN 
HYDRATED SILICA 
SODIUM TRIPOLYPHOSPHATE 
PEG-8 LAURATE 
SODIUM LAURYL SULFATE 
ISOPENTANE 
CARRAGEENAN 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SUCRALOSE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREEN (greenish blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0504-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/200901/31/2015
AQUAFRESH  ISO-ACTIVE
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0506
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
GLYCERIN 
HYDRATED SILICA 
SODIUM TRIPOLYPHOSPHATE 
PEG-8 LAURATE 
SODIUM LAURYL SULFATE 
ISOPENTANE 
CARRAGEENAN 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SUCRALOSE 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
ColorGREEN (greenish blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0506-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/200903/31/2013
AQUAFRESH  ISO-ACTIVE
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0524
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
GLYCERIN 
SORBITOL 
POLYETHYLENE GLYCOL 400 
SODIUM CITRATE 
SODIUM LAURYL SULFATE 
ISOPENTANE 
CARRAGEENAN 
XANTHAN GUM 
ZINC CHLORIDE 
SACCHARIN SODIUM 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:0135-0524-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/18/201109/30/2015
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 08/2014
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)