AQUAFRESH SENSITIVE MAXIMUM STRENGTH - potassium nitrate and sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare LP

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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 potassium nitrate and sodium fluoride   paste

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 0135-0132-03 1 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: 01/2011GlaxoSmithKline Consumer Healthcare LP