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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 soft bristle toothbrush
•: brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician
•: to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established
•: children under 2 years ask a dentist or physician

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, FD&C blue #1

Inactive ingredients (Deep Impac)t

Inactive ingredients (Lasting Impact)

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®

FLUORIDE TOOTHGEL

iso-active®

WHITENING

FOAMING GEL

FRESH IMPACT®

TRIPLE PROTECTION®

HEALTHY GUMS

STRONG TEETH

FRESH BREATH

WORKS BEYOND PASTE

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 Fresh Impact®, 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 white teeth while also helping to maintain healthy gums.

Aquafresh®, iso-active®, Fresh Impact®and 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

53998XC

Principal Display Panel

NDC 0135-0504-01

Aquafresh®

FLUORIDE TOOTHGEL

iso-active®

WHITENING

FOAMING GEL

DEEP 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 Deep ImpactTM, a distinctive invigorating 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®, Deep 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

53997XC

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

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

PURE BREATH ACTION

STRONG, HEALTHY TEETH FOR A LIFETIME

NET WT 4.3 oz (121.6g)

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

AQUAFRESH® TOOTHPASTE WITH TRIPLE PROTECTION® BENEFITS

HEALTHY GUMS

STRONG TEETH

FRESH BREATH

TAKE THE FEELING OF CLEAN TO THE EXTREME®

Aquafresh® Extreme Clean® Pure Breath Action iso-active® is a unique gel that transforms into an active foam to penetrate hard to reach places in your mouth. Aquafresh® Extreme Clean® Pure Breath Action for a thorough clean.

AQUAFRESH, ISO-ACTIVE, 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

www.Aquafresh.com

101041XA

AQUAFRESH ISO-ACTIVE
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0505
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN (greenish blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0135-0505-01	121.6 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2009

AQUAFRESH ISO-ACTIVE
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0504
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN (greenish blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0135-0504-01	121.6 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2009

AQUAFRESH ISO-ACTIVE
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0506
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN (greenish blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0135-0506-01	121.6 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2009

AQUAFRESH ISO-ACTIVE
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0524
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description
1	NDC:0135-0524-01	121.6 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/18/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 12/2012

Document Id: b12815f5-bd4b-4a7e-ac27-1a817b9cb3e9

Set id: 047f5ec4-42bb-4d21-b78d-71ba7159d53a

Version: 6

Effective Time: 20121213

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

AQUAFRESH iso-active

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