Label: PRO-DEN RX- sodium fluoride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 16, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • OTC - ACTIVE INGREDIENT

    Sodium Fluoride 0.044% w/w (0.02% w/v fluoride ion)

  • OTC - PURPOSE

    Anticavity

    Approved Uses

    • Aids in prevention of dental caries (cavities).
    • The combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

    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. Use only under guidance or supervision of a dentist or doctor.

    Directions: This is a fluoride treatment rinse, not a mouthwash.  Read directions carefully before using.

    Adults and Children
    6 yrs and older
                                                    		Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
    Children 6 to 12
                                                            		Instruct and supervise in good rinsing (to minimize swallowing).
    Children Under 6
    		Consult a dentist or doctor.

    Inactive Ingredients:

    Distilled water, monosodium phosphate, sodium benzoate, sodium saccharin, artificial color, artificial flavor.

    Made for and Distributed in US by:
    Zila Therapeutics, Inc.,

    P.O. Box 3889, Batesville, AR 72503

    1-800-228-5595

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    7f549575-figure-01
  • INGREDIENTS AND APPEARANCE
    PRO-DEN RX 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.044 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC ANHYDROUS (UNII: KH7I04HPUU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59883-168-16473 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/21/2008
    Labeler - Zila Therapeutics, Inc. (883514127)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zila Therapeutics, Inc.883514127MANUFACTURE
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!