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Name:Aquafreshsensitive Maximum Strength
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

AQUAFRESH SENSITIVE MAXIMUM STRENGTH - potassium nitrate and sodium fluoride paste 
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 ingredients

Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

  • builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets, or contact
  • aids in the prevention of dental cavities

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

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.

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, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician

Other information

  • store below 30°C (86°F)

Inactive ingredients

D&C red #30 lake, FD&C blue #1 lake, flavor, glycerin, hydrated silica, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

Questions or comments?

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

Principal Display Panel

Aquafresh®

FLOURIDE TOOTHPASTE

TRIPLE PROTECTION

Sensitive Maximum Strength*

Gently Whitens with regular brushing

Reduces Sensitivity

Fights Cavities

NET WT 5.6oz (158.7g)

Targets source of sensitive teeth pain

Soothes nerves

Reduces painful sensitivity

Fights cavities

What causes sensitive teeth?

When tooth enamel erodes or the gumline recedes, the unprotected tooth surface exposes tiny, microscopic holes that lead directly to nerves inside the tooth. These nerves are the source of sensitive teeth pain.

How can Aquafresh Sensitive Maximum Strength help?

Aquafresh Sensitive Maximum Strength targets the source of sensitive teeth pain. Its special formula soothes the nerves so that with regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth!

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the U.S.A.

Aqua®, Aquafresh®, Triple Protection®, and various design elements are trademarks of GlaxoSmithKline.

©2008 GlaxoSmithKline

www.Aquafresh.com

*maximum FDA sensitivity active ingredient

29974IA

Aquafresh Sensitive Maximum Strength carton


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM CATION 19.3 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 30  
ALUMINUM OXIDE  
FD&C BLUE NO. 1  
GLYCERIN  
HYDRATED SILICA  
SODIUM BENZOATE  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
SACCHARIN SODIUM  
SORBITOL  
TITANIUM DIOXIDE  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0132-03 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 158.7 g in 1 TUBE This package is contained within the CARTON (0135-0132-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/29/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 01/2011 GlaxoSmithKline Consumer Healthcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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