NEUTRAMAXX 5000 PLUS TURBO by Massco Dental A Division of Dunagin Pharmaceuticals

Drug Details [pdf]

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

NEUTRAMAXX 5000 PLUS TURBO
sodium fluoride paste

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63783-323
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g in 112 g

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	MINT (MINT FLAVOR)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63783-323-01	112 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/01/2011	12/01/2022

Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)

Name	Address	ID/FEI	Business Operations
Establishment
Massco Dental A Division of Dunagin Pharmaceuticals		008081858	manufacture(63783-323)

Revised: 12/2022

Document Id: 46f6e023-9984-4d08-883f-d04fb452924e

Set id: 79d12125-e930-4791-bba6-22c141dcd3c7

Version: 5

Effective Time: 20221214

Massco Dent