Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

Sensodyne Pronamel Fluoride Rinse

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1L
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0549

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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.

Directions
adults and children 6 years of age and older:
use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters into the cap (10mL mark on inside of cap): do not fill above the 10 mL mark
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not drink from the bottle
do not swallow the rinse
do not eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Other information
store at room temperature
do not use if safety seal is broken

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

NDC 0135-0549-01

SENSODYNE™

PRONAMEL®

FLUORIDE RINSE

Helps protect against the effects of Acid Erosion

Strengthens teeth

Helps protect against tooth decay

Freshens breath

DAILY PROTECTION

WINE ACIDS

FRUIT ACIDS

SODA ACIDS

IMPORTANT: Read instructions for proper use

NET WT 8.4 fl oz (250 mL)

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Germany

©2013 GlaxoSmithKline

Visit us at www.pronamel.com

Front Label: 102509XB

Back Label: 102511XC

SENSODYNE PRONAMEL  FLUORIDE RINSE
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0549
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0549-010.25 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/04/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 12/2015
 
GlaxoSmithKline Consumer Healthcare LP