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SENSODYNE

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

Antihypersensitivity

Anticavity

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

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.

  • 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 one 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
  • adults and children 12 years of age and older:
    • oApply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • oBrush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) and not more than three times a day, or as recommended by a dentist or physician. 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

store below 30°C (86°F)

Store below 25°C (77°F)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide

call toll-free 1-866-844-2797 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0484-03

SENSODYNE®

PRONAMEL®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

GENTLE WHITENING

STRENGTHENS AND RE-HARDENS ENAMEL

PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

ALPINE BREEZE®

NET WT 4.0 OZ (113g)

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

ACID PROTECTION FORMULA

USE WHENEVER YOU NORMALLY BRUSH

Helps protect enamel from the effects of acid erosion

Strengthens and re-harden enamel

Gently whitens tooth enamel

Contains fluoride for cavity protection

Specially formulated for people with sensitive teeth

Help protect your teeth against the effects acid erosion.

Dentists have reported a growing dental health concern due to changing modern diets: acid erosion. Even teeth without cavities can be affected.

*Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker, and sensitive. 

SENSODYNE PRONAMEL® Gentle Whitening toothpaste is formulated to protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

#1 Dentist Recommended Brand for Protection Against the Effects of Acid Erosion†

† Dentists have been recommending Sensodyne  for over 20 years. ProNamel is from the makers of Sensodyne and is highly recommened by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel has fluoride it helps protect against cavities too.

Visit us at: www.pronamel.com

This product contains no sugar.

SENSODYNE, SENSODYNE PRONAMEL, PRONAMEL, PRONAMEL DEVICE, ALPINE BREEZE and package design elements are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

30694XD

Principal Display Panel

NDC 0135-0460-01

SENSODYNE®

PRONAMEL®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

STRENGTHENS AND RE-HARDENS ENAMEL

PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

MINTESSENCE®

#1 Dentist Recommended Brand for Protection Against Acid Erosion †

NET WT 4.0 OZ (113g)

ACID PROTECTION FORMULA

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

USE WHENEVER YOU NORMALLY BRUSH

Helps protect the youthful appearance of teeth

Formulated with low abrasivity, balanced pH and an effective cleaning system

Has fluoride for cavity protection

Contains Potassium Nitrate clinically proven to relieve painful sensitivity in as little as two weeks

Help protect your enamel against the effects of acid erosion.

*Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

SENSODYNE PRONAMEL® MINTESSENCE® toothpaste is formulated to help protect against acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

† Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel has fluoride it helps protect against cavities too.

Visit us at: www.pronamel.com

This product contains no sugar.

SENSODYNE, PRONAMEL, MINTESSENCE and Design elements are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GlaxoSmithKline

30687XF

Principal Display Panel

NDC 0135-0520-02

SENSODYNE®

PRONAMEL®

DAILY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

FRESH BREATH

STRENGTHENS AND RE-HARDENS ENAMEL

PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

FRESH WAVE®

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

NET WT 0.8 OZ (23g)

Visit us at: www.pronamel.com

ACID PROTECTION FORMULA

ALWAYS FOLLOW THE LABEL

*Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

This product contains no sugar.

SENSODYNE, SENSODYNE PRONAMEL, PRONAMEL, PRONAMEL DEVICE, FRESH WAVE and package design elements are trademarks of the GlaxoSmithKline group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GSK

101178XC

Principal Display Panel

NDC 0135-0568-04

Sensodyne®

PRONAMEL®

DAILY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

MULTI-ACTION

STRENGTHENS AND RE-HARDENS ENAMEL PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

Cleansing Mint

NEW

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

NET WT 4.0 OZ (113g)

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Protection Against the Effects of Acid Erosion†

MULTI-ACTION

ACID PROTECTION FORMULA

Brushing twice a day with Pronamel helps to:

Protect enamel against the effects of acid erosion

Restore natural whiteness

Clean effectively and freshen breath

Provide cavity protection

Maintain healthy teeth and gums

Pronamel is also suitable for people with sensitive teeth.

Help protect your enamel against the effects of acid erosion.

Dentists have reported a growing dental health concern due to changing modern diets: ‘acid erosion’. Even teeth without cavities can be affected.

*Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

SENSODYNE PRONAMEL ® Multi-Action toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides the benefits of a regular toothpaste. Plus, its cleansing mint flavor helps keep your mouth feeling fresh and clean.

†Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And since ProNamel toothpaste has fluoride it helps protect against cavities too.

ALWAYS FOLLOW THE LABEL

This product contains no sugar.

SENSODYNE, SENSODYNE PRONAMEL, PRONAMEL, PRONAMEL DEVICE and package design elements are trademarks of the GlaxoSmithKline group of companies.

©2013 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

103425XA

SENSODYNE

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0484
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
HYDRATED SILICA
GLYCERIN
polyethylene glycol 400
COCAMIDOPROPYL BETAINE
titanium dioxide
XANTHAN GUM
saccharin sodium
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0484-03 22.6 in 1 TUBE
3 113 in 1 TUBE
4 NDC:0135-0484-04 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-10-18


SENSODYNE

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0460
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
HYDRATED SILICA
GLYCERIN
polyethylene glycol 400
COCAMIDOPROPYL BETAINE
XANTHAN GUM
saccharin sodium
titanium dioxide
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0460-02 22.6 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-10-18


SENSODYNE

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0520
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
HYDRATED SILICA
GLYCERIN
polyethylene glycol 400
COCAMIDOPROPYL BETAINE
XANTHAN GUM
saccharin sodium
titanium dioxide
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0520-02 23 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-04-14


SENSODYNE

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0568
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
HYDRATED SILICA
GLYCERIN
COCAMIDOPROPYL BETAINE
XANTHAN GUM
saccharin sodium
MICA
titanium dioxide
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0568-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-12-09


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Be sure to consult your doctor before taking any medication!
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