Sensodyne Pronamel description, usages, side effects, indications, overdosage, supplying and lots more!

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Sensodyne Pronamel

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Anticavity

aids in the prevention of dental cavities

When using this product

  • •if irritation occurs, discontinue use
  • •may cause staining

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • adults and children 6 years of age and older:
    • ouse once a day after brushing your teeth with a toothpaste
    • oremove cap
    • opour 10 milliliters into the cap (10mL mark on inside of cap): don not fill above the 10 mL mark
    • ovigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    • odo not drink from the bottle
    • odo not swallow the rinse
    • odo not eat or drink for 30 minutes after rinsing
    • oinstruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • osupervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor
  • •store at room temperature
  • •do not use if safety seal is broken

water, glycerin, sorbitol, poloxamer 338, PEG-60 hydrogenated castor oil, VP/VA copolymer, sodium benzoate, cellulose gum, flavor, methylparaben, propylparaben, cetylpyridinium chloride, sodium saccharin, xanthan gum, disodium phosphate, sodium phosphate, FD&C Blue No.1

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

Principal Display Panel

NDC 0135-0549-01

SENSODYNE™

PRONAMEL®

FLUORIDE RINSE

NEW

Helps protect against the effects of acid erosion

Helps potect against tooth decay

Helps re-harden acid softened enamel

Fresh mint taste

Alcohol free

ACID PROTECTION FORMULA

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

IMPORTANT: Read instructions for proper use

NET WT 8.4oz (250 mL )

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2012 GlaxoSmithKline

Visit us at www.pronamel.com

Front Label: 102509XA

Back Label: 102511XB

Sensodyne Pronamel

sodium fluoride MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0549
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.2 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
sorbitol
Poloxamer 338
PEG-60 HYDROGENATED CASTOR OIL
COPOVIDONE K25-31
SODIUM BENZOATE
CARBOXYMETHYLCELLULOSE SODIUM
METHYLPARABEN
PROPYLPARABEN
cetylpyridinium chloride
saccharin sodium
XANTHAN GUM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
sodium phosphate
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0549-01 0.25 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-02-04


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