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

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.

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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

Aquafresh IsoActive Whitening Fresh Impact 4.3 oz label

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

Aquafresh IsoActive Whitening Deep Impact 4.3 oz label

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

Aquafresh Lasting Impact Label

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 IsoActive Pure Breath Extreme Clean 4.3oz (121.6g) label
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 (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPENTANE (UNII: ZH67814I0O)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color GREEN (greenish blue) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0505-01 121.6 g in 1 CAN; Type 0: Not a Combination Product 09/01/2009 01/31/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/01/2009 01/31/2015
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 (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPENTANE (UNII: ZH67814I0O)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color GREEN (greenish blue) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0504-01 121.6 g in 1 CAN; Type 0: Not a Combination Product 09/01/2009 01/31/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/01/2009 01/31/2015
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 (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPENTANE (UNII: ZH67814I0O)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
Color GREEN (greenish blue) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0506-01 121.6 g in 1 CAN; Type 0: Not a Combination Product 09/01/2009 03/31/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/01/2009 03/31/2013
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 (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPENTANE (UNII: ZH67814I0O)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0524-01 121.6 g in 1 CAN; Type 0: Not a Combination Product 07/18/2011 09/30/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 07/18/2011 09/30/2015
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 8/2014
Document Id: b539fc3b-61c7-40f4-81d6-0a447e617626
Set id: 047f5ec4-42bb-4d21-b78d-71ba7159d53a
Version: 8
Effective Time: 20140815
 
GlaxoSmithKline Consumer Healthcare LP