Label: NEUTRA MAXX 5000- sodium fluoride gel

  • NDC Code(s): 63783-504-06
  • Packager: Massco Dental A Division of Dunagin Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated December 17, 2023

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  • ACTIVE INGREDIENTS

    ACTIVE INGREDIENT                                      PURPOSE

    SODIUM FLUORIDE (NaF) 1.1% (w/v)               ANTICAVITY

    INACTIVE INGREDIENTS

    DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .

  • USE

    USE: AIDS IN THE PREVENTION OF DENTAL DECAY IN PEDIATRIC PATIENTS AND ADULTS

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR BRUSHING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    DIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   

    ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

  • WARNINGS

    WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

  • PACKAGE LABEL

    NEUTRA MAXX 5000PPM GEL  REFRESHING MINT FLAVOR

    THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE  1.1% SODIUM FLUORIDE 5% POTASSIUM  NITRATE XYLITOL SLS FREE Rx ONLY.  NET WT 4.3 oz  (120 g)

    MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS  GRAVETTE, AR 72736  THE MEDICINE AVAILABLE EXCLUSIVELY THROUGH YOUR DENTAL OFFICE. 

    OTHER INFORMATION: STORE AT ROOM TEMPERATURE   QUESTION? COMMENTS? CALL 1-479-787-5168 M-F 9AM TO 5PM CST

    NEUTRA MAXX GEL LABEL

  • INGREDIENTS AND APPEARANCE
    NEUTRA MAXX 5000 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.428 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63783-504-06120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/01/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/1989
    Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Massco Dental A Division of Dunagin Pharmaceuticals008081858manufacture(63783-504)
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