AQUAFRESH ISO-ACTIVE - sodium fluoride gel 
GlaxoSmithKline Consumer Healthcare LP

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Drug Facts

Active ingredient

Sodium fluoride

(0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

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. Don 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 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, D&C yellow #10, FD&C blue #1

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

Questions or comments?

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

Principal Display Panel Fresh Impact

Aquafresh®

FLUORIDE TOOTHGEL

iso-active®

FOAMING GEL

WHITENING

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

©2010 GlaxoSmithKline

53998XC

Principal Display Panel Deep Impact

Aquafresh®

FLUORIDE TOOTHGEL

iso-active®

FOAMING GEL

WHITENING

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

©2010 GlaxoSmithKline

53997XC

Principal Display Panel Lasting Impact

Aquafresh®

FLUORIDE TOOTHGEL

iso-active®

FOAMING GEL

WHITENING

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

AQUAFRESH  ISO-ACTIVE sodium fluoride   gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.15 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 # NDC Package Description Multilevel Packaging 1 0135-0505-01 121.6 g In 1 CAN None

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 NDC Product Code (Source) 0135-0504 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.15 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 # NDC Package Description Multilevel Packaging 1 0135-0504-01 121.6 g In 1 CAN None

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 NDC Product Code (Source) 0135-0506 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.15 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 # NDC Package Description Multilevel Packaging 1 0135-0506-01 121.6 g In 1 CAN None

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

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2011GlaxoSmithKline Consumer Healthcare LP