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AQUAFRESH SENSITIVE MAXIMUM STRENGTH

Dosage form: paste
Ingredients: POTASSIUM NITRATE 50mg in 1g, SODIUM FLUORIDE 1.5mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0605

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 (0135-0132)

Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)

Active ingredient (0135-0605)

Potassium nitrate (5%)

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

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

Use (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: (0135-0132)
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

Stop use and ask a dentist if (0135-0605)
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 (0135-0132)
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 no 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

Directions (0135-0605)
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? (0135-0132)

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

Questions or comments? (0135-0605)

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**

healthy gums†
strong teeth
fresh breath

from Fluoride

smooth mint

NET WT 5.6 OZ (158.8g)

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

AQUAFRESH  SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0605
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
XANTHAN GUM 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
MENTHOL, UNSPECIFIED FORM 
D&C RED NO. 30 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (smooth mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0605-011 TUBE in 1 CARTON
1158.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/17/2017
AQUAFRESH  SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0132
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
D&C RED NO. 30 
Packaging
#Item CodePackage Description
1NDC:0135-0132-031 TUBE in 1 CARTON
1158.7 g in 1 TUBE
2NDC:0135-0132-071 TUBE in 1 CARTON
2198.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/29/2011
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 02/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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