PRO-DEN RX- stannous fluoride rinse 
Den-mat Holdings, Llc

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ProDenRx

Drug Facts

Active Ingredient

Stannous Fluoride 0.63% w/w

(0.19% w/v fluoride ion)

Purpose

anticavity

Uses

Warnings

When using this product it may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

Children 6 to 12 years of age:

Children under 6 years of age:

Other information

For your protection, do not use if seal under the cap is broken or missing.

Inactive ingredients

flavor, glycerin, methylparaben, propylparaben, sodium saccharin

Principal Display Panel - Carton Label

NDC 59883-720-08

pro-denRx ®

dye
free
rinse

0.63 % stannous fluoride

cool mint
flavor

IMPORTANT:

Read directions for proper use.

10 fl. oz.
(283.5 g)

Figure

Principal Display Panel

NDC 59883-720-08

pro-denRx ®

dye

free

rinse

0.63 % stannous fluoride

mint

flavor

IMPORTANT:

Read directions for proper use.

10 fl. oz.

(283.5 g)

Figure

PRO-DEN RX 
stannous fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-720
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-720-081 in 1 CARTON10/31/2008
1283.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02110/31/2008
Labeler - Den-mat Holdings, Llc (809857704)

Revised: 11/2023
Document Id: 0a95fcbe-e811-031d-e063-6294a90aec1b
Set id: 9036aa8a-59b1-41b0-b3cb-529d3303a1c0
Version: 6
Effective Time: 20231120
 
Den-mat Holdings, Llc