NEUTRAMAXX 5000 PLUS TURBO- sodium fluoride paste 
Massco Dental A Division of Dunagin Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT SECTION

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

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

INDICATIONS SECTION

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

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM

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.

QUESTIONS? COMMENTS? SECTION

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

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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NEUTRAMAXX 5000 PLUS TURBO 
sodium fluoride paste
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
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 (UNII: SB8ZUX40TY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-500-04112 g in 1 TUBE; Type 0: Not a Combination Product09/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2011
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(63783-500)

Revised: 12/2023
Document Id: 5e2c9003-948d-4b08-8bdd-fdf3c751cb4c
Set id: 3c7584f1-b652-4d82-99e7-10da0ee242c1
Version: 9
Effective Time: 20231217
 
Massco Dental A Division of Dunagin Pharmaceuticals