Pro-Den Rx

Manufacturer
Den-mat Holdings, Llc
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:37

Label at a glance#

ProductPro-Den Rx
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity

Dosage and administration

Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older: Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.63% w/w

(0.19% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental caries (cavities).
  • Control of perio infection
  • Relief of dentin sensitivity

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Do not use before mixing with water
  • Use immediately after preparing the rinse

Adults and children 6 years of age and older:

  • Use as directed by a dental professional
  • Use once a day after brushing your teeth with a toothpaste or as directed by your dentist
  • Remove cap and seal and replace with pump
  • Rotate spout counter clockwise to extend
  • Depress pump until medicine comes to the tip of the pump
  • Put 1/8 oz. (approx. 2 pump strokes) of concentrated Pro-DenRx Rinse into the provided mixing vial
  • Add water to 1 oz. line on mixing vial
  • Tightly snap on the cap and shake well
  • Vigorously swish between your teeth 1/2 of mixture for one minute and then spit out
  • Repeat procedure with remaining mixture
  • Rinse mixing vial with water after use
  • Do not swallow the rinse
  • Do not eat or drink for 30 minutes after rinsing

Children 6 to 12 years of age:

  • Instruct children 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 For home irrigation
  • Prepare 1 oz. of Pro-DenRx Rinse as described above
  • Pour into irrigator reservoir, add 4 oz. of water and mix thoroughly
  • Use irrigator as directed
  • Rinse irrigator with water after use

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, glycerin, methylparaben, propylparaben, sodium saccharin

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Figure

Principal Display Panel

PACKAGE LABEL.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)

FigureFigure

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-720-08Pro-Den Rx283.5 g in 1 BOTTLERINSE283.56
59883-720-08Pro-Den Rx1 in 1 CARTONRINSE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-720PRO-DEN RX (STANNOUS FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC]6Current NDC, Legacy NDC, 2 package rows20231216_9036aa8a-59b1-41b0-b3cb-529d3303a1c0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-72059883-720-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii+route
40 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
ndc (package): 59883-720-08
ndc (product): 59883-720
ndc11 (package): 59883072008
spl id: 0a95fcbe-e811-031d-e063-6294a90aec1b
spl set id: 9036aa8a-59b1-41b0-b3cb-529d3303a1c0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.