SPL v9
SPL
SPL Set ID 3c7584f1-b652-4d82-99e7-10da0ee242c1
Route
ORAL
Published
Effective Date 2020-01-02
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 g)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Xylitol Potassium Nitrate Mint Polyethylene Glycol 8000 Carboxymethylcellulose Titanium Dioxide Saccharin Sodium Dimethicone Poloxamer 407

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-09-01

Description

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE


Medication Information

Description

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

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

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Warnings Section

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

Indications Section

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

Active Ingredient Section

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

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.

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

Questions? Comments? Section

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

Keep Out of Reach of Children Section

AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM


Structured Label Content

Package Label (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

res

Warnings Section (WARNINGS SECTION)

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

Indications Section (INDICATIONS SECTION)

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

Active Ingredient Section (ACTIVE INGREDIENT SECTION)

DRUG FACTS  ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Directions: Use As Directed (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.

Inactive Ingredient Section (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

Questions? Comments? Section (QUESTIONS? COMMENTS? SECTION)

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

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)