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Neutramaxx 5000 Plus Turbo

Generic Name: sodium fluoride
Dosage Form: oral paste

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 
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
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 Operations
Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture
Revised: 02/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals



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