Label: PRO-DEN RX- sodium fluoride rinse

  • NDC Code(s): 59883-920-16, 59883-922-16
  • Packager: Den-mat Holdings, Llc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 28, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • Description:

    Pro-DenRx ® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.

  • Active Ingredient:

    Sodium Fluoride 0.2% w/w (0.09% w/w fluoride ion).

  • Inactive Ingredients:

    Purified water, Cetyl Pyridinium Chloride, citric acid, potassium sorbate, sucralose, flavor and Sodium Hydroxide.

  • Clinical Pharmacology:

    Sodium fluoride when used topically promotes remineralization, increases resistance of teeth to acid dissolution, and impedes the cariogenic microbial process.

  • Indications and Usage:

    Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx ® Rinse is ready to use, convenient and thus increases compliance.

    Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.

  • Contraindications:

    Do not use in children under age 6 years unless recommended by a dentist or physician.

  • Warnings:

    PLEASE 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. READ DIRECTIONS CAREFULLY BEFORE USING.

  • Precautions:

    General: Not for systemic treatment. DO NOT SWALLOW.

  • Adverse Reactions:

    NONE

  • Overdosage:

    Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.

  • Dosage and Administration:

    Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of Pro-DenRx® 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using.

  • How Supplied:

    For home use: Plastic bottle containing 16 fl. oz. (473 ml) Cool Mint: NDC 59883-920-16.

    RX only:

    Storage: Store at Room Temperature

    Reorder 1-800-433-6628
    Manufactured for
    Den-Mat Holdings, LLC 1017 W. Central Ave.
    Lompoc, CA 93436

    ©2014 Den-Mat Holdings, LLC. All rights reserved.

  • Principal Display Panel - Bottle Label

    NDC 59883-920-16

    pro-denRx®

    dye
    free
    rinse

    0.2% sodium fluoride

    mint
    flavor

    Contains: 0.2% Sodium Fluoride in a Neutral
    Aqueous Solution (0.09% Fluoride Ion)

    16 fl. oz.
    (473 ml)

    Principal Display Panel - Bottle Label
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image not available
  • INGREDIENTS AND APPEARANCE
    PRO-DEN RX 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59883-920
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-920-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/21/2008
    PRO-DEN RX 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59883-922
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (BERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-922-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/200812/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/21/200812/31/2014
    Labeler - Den-mat Holdings, Llc (809857704)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!