Label: NEUTRAMAXX 5000 TCP - sodium fluoride paste, dentifrice

  • NDC Code(s): 63783-501-04
  • Packager: Massco Dental A Division of Dunagin Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

Drug Label Information

Updated 02/12

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

  • Active Ingredient Section

    DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

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  • Purpose Section

    For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

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  • Keep Out of Reach of Children Section

    As with all medications, keep out of reach of children.

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  • Indications and Usage Section

    NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

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  • Warning Section

    Warnings  Do not swallow   For topical use only  

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  • Directions: Use As Directed Section

    This prescription dentifrice is recommended for adults and pediatric patients 6 years and older

    Apply a thin ribbon of NeutraMaxxtm  5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes.

    After brushing  ADULTS - Expectorate, do not eat for 30 minutes.   CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water.   Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

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  • Inactive Ingredient Section

    Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

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  • Questions? Comments? Section

    Call 1-479-787-5168  M-F 9am to 5 pm CST

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  • Package Label

    REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

    ANTI-CAVITY TOOTHPASTE  NeutraMaxx tm 5000 TCP  XYLITO1.1% Neutral Sodium Fluoride 5000 ppm  Sweetened with Xylitol

    DOES NOT CONTAIN SODIUM LAURYL SULFATE  RX ONLY  Net wt. 4 oz (112 G)

    Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Gravette, AR  (479) 787-5168  www.masscodental.net

    NeutraMax 5000 TCP Label

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  • INGREDIENTS AND APPEARANCE
    NEUTRAMAXX 5000 TCP 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-501
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g  in 112 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (REFRESHING MINT FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-501-04 112 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 08/01/2011
    Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
    Establishment
    Name Address ID/FEI Business Operations
    Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture
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