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SENSODYNE

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Anticavity, Antihypersensitivity

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

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

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:
    • oapply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • obrush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not 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 doctor
  • •products containing stannous fluoride may product surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • •this product is specifically formulated to help prevent staining
  • •store below 25°C (77°F)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

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

Principal Display Panel

NDC 0135-0548-02

SENSODYNE®

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

REPAIR & PROTECT

new

NET WT 3.4 oz (96.4g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Proven relief and daily protection for sensitive teeth*

Relieves the sensitivity pain and helps to stop it from coming back

Contains fluoride for cavity protection

Helps keep breath minty fresh

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect?

Now there is a Sensodyne toothpaste that can help repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

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

Visit us at: ww.sensodyne.com

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

ALWAYS FOLLOW THE LABEL

102432XA

Principal Display Panel

NDC 0135-0547-02

SENSODYNE®

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

EXTRA FRESH

REPAIR & PROTECT

new

NET WT 3.4 oz (96.4g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Proven relief and daily protection for sensitive teeth*

Relieves the sensitivity pain and helps to stop it from coming back

Contains fluoride for cavity protection

Leaves your mouth feeling clean and fresh

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect Extra Fresh?

Now there is a Sensodyne toothpaste that can help repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

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

Visit us at: ww.sensodyne.com

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

ALWAYS FOLLOW THE LABEL

102433XA

SENSODYNE

stannous fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0548
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 1.5 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
polyethylene glycol 400
HYDRATED SILICA
SODIUM TRIPOLYPHOSPHATE
SODIUM LAURYL SULFATE
titanium dioxide
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCAMIDOPROPYL BETAINE
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 96.4 in 1 TUBE
2 23 in 1 TUBE
3 NDC:0135-0548-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-02-04


SENSODYNE

stannous fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0547
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 1.5 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
polyethylene glycol 400
HYDRATED SILICA
SODIUM TRIPOLYPHOSPHATE
SODIUM LAURYL SULFATE
titanium dioxide
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
saccharin sodium
COCAMIDOPROPYL BETAINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 96.4 in 1 TUBE
2 NDC:0135-0547-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-02-04


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Be sure to consult your doctor before taking any medication!
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