Neutramaxx 5000 Plus Turbo Paste
FDA Label NDC 63783-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Massco Dental A Division Of Dunagin Pharmaceuticals for the product Neutramaxx 5000 Plus Turbo (NDC 63783-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient section, inactive ingredient section, indications section, warnings section, keep out of reach of children section, directions: use as directed, questions? comments? section, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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