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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

When using this product,

if irritation occurs discontinue use.

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, please visit your dentist

Flammable.

Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

water, sorbitol, hydrated silica, glycerin, PEG-8, isopentane, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, carrageenan, sodium saccharin, sodium hydroxide, blue 1, yellow 10

water, hydrated silica, sorbitol, glycerin, PEG-8, isopentane, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, carrageenan, sodium saccharin, sodium hydroxide, blue 1

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

Principal Display Panel

NDC 0135-0518-01

SENSODYNE ®

PRONAMEL ®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

DAILY PROTECTION

iso-active ®

Re-hardens and strengthens enamel.

Protects against the effects of acids in:

FRUIT

SODA

WINE

NET WT 4.3 OZ (121.6g)

9 OUT OF 10 DENTIST RECOMMENDED BRAND

HOW DOES IT WORK?

New Pronamel® iso-active® transforms into a microfine foam during brushing, protecting against the effects of acid erosion by re-hardening your enamel with daily brushing.

SENSODYNE, PRONAMEL, ISO-ACTIVE, and package design elements are registered trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle - when empty.

Does not contain CFCs.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

www.pronamel.com

©2011 GlaxoSmithKline

100810XD

Principal Display Panel

NDC 0135-0519-01

SENSODYNE ®

PRONAMEL ®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

GENTLE WHITENING

iso-active ®

Re-hardens and strengthens enamel.

Protects against the effects of acids in:

FRUIT

SODA

WINE

NET WT 4.3 OZ (121.6g)

9 OUT OF 10 DENTIST RECOMMENDED BRAND

HOW DOES IT WORK?

New Pronamel® iso-active® transforms into a microfine foam during brushing, protecting against the effects of acid erosion by re-hardening your enamel with daily brushing.

SENSODYNE, PRONAMEL, ISO-ACTIVE, and package design elements are registered trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle - when empty.

Does not contain CFCs.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

www.pronamel.com

©2011 GlaxoSmithKline

100807XD

SENSODYNE

potassium nitrate and sodium fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0518
Route of Administration DENTAL 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
ISOPENTANE
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
XANTHAN GUM
CARRAGEENAN
saccharin sodium
SODIUM HYDROXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10

Product Characteristics

Color
BLUE (blue and green)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0518-01 121.6 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-14


SENSODYNE

potassium nitrate and sodium fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0519
Route of Administration DENTAL 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
HYDRATED SILICA
sorbitol
GLYCERIN
polyethylene glycol 400
ISOPENTANE
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
XANTHAN GUM
CARRAGEENAN
saccharin sodium
SODIUM HYDROXIDE
FD&C BLUE NO. 1

Product Characteristics

Color
BLUE (Blue and Green)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0519-01 121.6 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-14


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Be sure to consult your doctor before taking any medication!
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