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SENSODYNE

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Sodium fluoride (0.15% w/v fluoride ion)

Anticavity

aids in the prevention of dental cavities

Keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

  • adults and children 2 years and older
    • ∘apply toothpaste onto a soft bristle toothbrush
    • ∘brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician
    • ∘to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established
  • children under 2 years ask a dentist or physician
  • •store below 30°C (86°F)

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

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

Helps protect against the effects of acid erosion

Helps harden tooth enamel

Helps protect against cavities

Developed with dentists

Gentle mint taste

Developed with dentists to help protect children’s teeth from acid wear

Everyone recognizes sugar-related tooth decay as a major issue in children’s oral health. However, dentists are increasingly concerned about the effects of acid erosion, caused by acids found in fruits, juices, and soft drinks in today’s diet. Most children’s permanent teeth come through between the ages of 6-13. These new teeth along with their baby teeth are vulnerable to attack from acids. These acids soften the enamel, allowing it to be slowly worn away. Once the enamel’s gone, it’s gone forever.

New Sensodyne for Children is an everyday fluoride toothpaste specially formulated in collaboration with dentists to strengthen the tooth enamel and to help protect your children’s teeth from the effects of acid erosion as well as tooth decay. Because Sensodyne ProNamel is specially formulated for children, it does not contain an anti-sensitivity ingredient.

This product contains no sugar.

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

www.pronamel.com

Principal Display Panel

NDC 0135-0485-01

SENSODYNE®

PRONAMEL™

DAILY FLUORIDE TOOTHPASTE

for Children

Gentle Mint

HELPS PROTECT AGAINST THE EFFECTS OF ACID EROSION

PROTECTS AGAINST CAVITIES

Developed with dentists

Helps protect against acid wear caused by acidic food and drinks

NET WT 3.4 OZ (96.4g)

©2011 GlaxoSmithKline

30659XC

SENSODYNE

sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0485
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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
Sucralose
titanium dioxide
SODIUM HYDROXIDE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0485-01 96.5 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-10-18


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