Label: NEUTRAMAXX 5000 TCP - sodium fluoride paste, dentifrice 

  • Label RSS
  • 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 LABEL Item Code (Source) NDC:63783-501
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.1 g  in 112 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    HYDRATED SILICA  
    POLYETHYLENE GLYCOL 8000  
    CARBOXYMETHYLCELLULOSE  
    XYLITOL  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    TITANIUM DIOXIDE  
    SACCHARIN SODIUM DIHYDRATE  
    TRIBASIC CALCIUM PHOSPHATE  
    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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