AQUAFRESH SENSITIVE MAXIMUM STRENGTH- potassium nitrate and sodium fluoride paste

Drug Details [pdf]

Active ingredient (0135-0132)

Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)
Active ingredients (0135-0605)

Potassium Nitrate (5%)*

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

*maximum FDA sensitivity active ingredient
Purpose

Antihypersensitivity

Anticavity
Use (0135-0132)
- builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets, or contact
- aids in the prevention of dental cavities
Uses (0135-0605)
- aids in the prevention of dental cavities.
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Warnings
When using this product,

if irritation occurs discontinue use.
Stop use and ask a dentist if
- the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
- pain/sensitivity still persists after 4 weeks of use.
Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older:
  - apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  - brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Other information
- store below 30°C (86°F)
Inactive ingredients (0135-0132)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin, sodium benzoate, blue 1 lake, red 30 lake
Inactive ingredients (0135-0605)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, red 30, blue 1
Questions or comments?

Call toll-free 1-800-897-5623
Principal Display Panel
NDC: 0135-0132-03

Aquafresh®

fluoride toothpaste for sensitive teeth

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength*

sensitive

Sugar Acid Protection**
- healthy gums†
- strong teeth
- fresh breath
From Fluoride

smooth mint

NET WT 5.6 OZ (158.7g)

Aquafresh® Maximum Strength*Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy.

With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

**With Sugar Acid

targets source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

*maximum FDA sensitivity active ingredient

103265XC
Principal Display Panel
NDC: 0135-0605-01

Aquafresh®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength* sensitive

Sugar Acid Protection**

from Fluoride
- healthy gums†
- strong teeth
- fresh breath
smooth mint

NET WT 5.6 OZ (158.8 g)

Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed of the GSK group of companies.

GSK Consumer Healthcare Warren, NJ 07059

*maximum FDA sensitivity active ingredient

©2015 GSK or its licensor.

105481XA

$C:\Users\sh821028\Pictures\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion.$

INGREDIENTS AND APPEARANCE

AQUAFRESH SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0132
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0135-0132-03	1 in 1 CARTON	03/29/2011	09/30/2018
1		158.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0132-07	1 in 1 CARTON	03/29/2011	09/30/2018
2		198.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/29/2011	09/30/2018

AQUAFRESH SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0605
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (smooth mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0135-0605-01	1 in 1 CARTON	02/17/2017
1		158.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/17/2017

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Trademark Results [AQUAFRESH]

Mark Image Registration \| Serial	Company Trademark Application Date
AQUAFRESH 86552488 not registered Dead/Abandoned	Inman, Nick 2015-03-04
AQUAFRESH 85044552 not registered Dead/Abandoned	GlaxoSmithKline LLC 2010-05-21
AQUAFRESH 78460244 2929043 Dead/Cancelled	GLAXOSMITHKLINE LLC 2004-08-02
AQUAFRESH 78448194 2985544 Live/Registered	GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC 2004-07-09
AQUAFRESH 78385905 2935093 Dead/Cancelled	GLAXOSMITHKLINE LLC 2004-03-17
AQUAFRESH 78027834 not registered Dead/Abandoned	Valterra Products, Inc. 2000-09-27
AQUAFRESH 76242063 2706176 Live/Registered	GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC 2001-04-17
AQUAFRESH 76241924 2699482 Dead/Cancelled	SmithKline Beecham Corporation 2001-04-17
AQUAFRESH 76241913 2706175 Live/Registered	GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC 2001-04-17
AQUAFRESH 76035013 2754841 Live/Registered	GLAXOSMITHKLINE CONSUMER HEALTHCARE (US) IP LLC 2000-04-21
AQUAFRESH 75914718 2503053 Dead/Cancelled	SmithKline Beecham Corporation 2000-02-10
AQUAFRESH 75914704 2503052 Dead/Cancelled	SmithKline Beecham Corporation 2000-02-10

AQUAFRESH SENSITIVE MAXIMUM STRENGTH- potassium nitrate and sodium fluoride paste

AQUAFRESH by

Drug Labeling and Warnings

Drug Details [pdf]

When using this product,

Stop use and ask a dentist if

Keep out of reach of children.

Trademark Results [AQUAFRESH]