SENSODYNE PRONAMEL FLUORIDE RINSE- sodium fluoride mouthwash 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 8.4 oz label
SENSODYNE PRONAMEL  FLUORIDE RINSE
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0549
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 338 (UNII: F75JV2T505)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
COPOVIDONE (UNII: D9C330MD8B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0549-010.25 L in 1 BOTTLE; Type 0: Not a Combination Product02/04/201302/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/04/201302/29/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2017
Document Id: dc4ff909-66ee-4abf-a62f-9a87d0b0ab69
Set id: 51e524b5-4d81-41e7-8ccd-cc17fbb81fef
Version: 4
Effective Time: 20170324
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC