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 ingredient

Potassium nitrate (5%)

Sodium fluoride (0.15 w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Use

•
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

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 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 physician

Other information

•
store below 30°C (86°F)

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

NDC 0135-0132-03

Aquafresh®

toothpaste for sensitive teeth & cavity protection

triple protection®

maximum strength*

sensitive

+gently whitening†

•
healthly gums
•
strong teeth
•
fresh breath

smooth mint

NET WT

5.6oz (158.7g)

Aquafresh® Triple Protection® 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.

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

helps maintain healthy gums with regular brushing.

For lots of reasons to smile

visit www.Aquafresh.com

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of GlaxoSmithKline group of companies.

*maximum FDA sensitivity active ingredient

†with regular brushing

101923XA

Aquafresh Sensitive 5.6 carton
AQUAFRESH  SENSITIVE MAXIMUM STRENGTH
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0132-031 in 1 CARTON
1158.7 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 LP (828924212)

Revised: 2/2014
Document Id: 6d24dd6d-069f-4974-a13f-5fb70a0101cb
Set id: 76adbccb-0812-4407-a6fc-a57e6f144fbb
Version: 3
Effective Time: 20140211
 
GlaxoSmithKline Consumer Healthcare LP