Label: NEUTRAMAXX 5000 PLUS TURBO - sodium fluoride paste

  • 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 Item Code (Source) NDC:63783-500
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    MINT (UNII: FV98Z8GITP)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    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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