Label: NEUTRAMAXX 5000 PLUS TURBO - sodium fluoride paste 

  • Label RSS
  • NDC Code(s): 63783-500-04
  • 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

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  • ACTIVE INGREDIENT SECTION

    DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

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  • INACTIVE INGREDIENT SECTION

    INACTIVE INGREDIENTS: FILTERED WATER, SORBITAL, HYDRATED SILICA, GLYCERINE, XYLITOL, POTASSIUM NITRATE, MINT FLAVOR, PEG,CARBOXYMETHYLCELLULOSE, TITANIUM DIOXIDE, SODIUM SACCHARIN, DIMETHICONE, POLOXOMER 407

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  • INDICATIONS SECTION

    INDICATIONS   NEUTRAMAXXtm 5000 PLUS TURBO IS A SELF-APPLIED DENTIFRICE FOR PREVENTION OF TOOTH DECAY, ORTHODONTIC DECALCIFICATION AND HYPERSENSITIVITY

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  • WARNINGS SECTION

    DO NOT SWALLOW    FOR TOPICAL USE ONLY    AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREN

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  • KEEP OUT OF REACH OF CHILDREN SECTION

    AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM

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  • DIRECTIONS: USE AS DIRECTED

    THIS PRESCRIPTION DENTIFRICE IS RECOMMENDED FOR ADULTS AND PEDIATRIC PATIENTS 6 YEARS AND OLDER.

    APPLY A THIN RIBBON OF NEUTRAMAXXtm 500 PLUS TURBO ALONG THE LENGTH OF THE TOOTHBRUSH NO MORE THAN "PEA SIZE" TOTAL DOSE. BRUSH FOR 2 MINUTES

    AFTER BRUSHING ADULTS-EXPECTORATE; DO NOT EAT OR DRINK 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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  • QUESTIONS? COMMENTS? SECTION

    CALL 1-479-5168 M-F 9AM TO 5PM CST

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  • PACKAGE LABEL

    PROFESSIONAL CLEANING SYSTEM  NEUTRAMAXXtm 5000 PLUS TURBO  REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

    1.1% NEUTRAL SODIUM FLUORIDE 5000PPM TOOTHPASTE WITH 5% POTASSIUM NITRATE SWEETENED WITH XYLITOL  DOES NOT CONTAIN SODIUM LAURYL SULFATE  RX ONLY  NET WT. 4 OZ (112 G)  NDC 63783-3233-112

    MAUNFACTURES BY: MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, ar (479) 787-5168  WWW.MASSCODENTAL.NET

    NEUTRAMAXX 5000 PLUS TURBO LABEL

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  • INGREDIENTS AND APPEARANCE
    NEUTRAMAXX 5000 PLUS TURBO 
    sodium fluoride paste
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63783-500
    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  
    GLYCERIN  
    XYLITOL  
    POTASSIUM NITRATE  
    MINT  
    POLYETHYLENE GLYCOL 8000  
    CARBOXYMETHYLCELLULOSE  
    TITANIUM DIOXIDE  
    SACCHARIN SODIUM DIHYDRATE  
    DIMETHICONE  
    POLOXAMER 407  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (MINT FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63783-500-04 112 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2011
    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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