Neutra Maxx

Dosage Form: oral gel

ACTIVE INGREDIENTS

ACTIVE INGREDIENT                                      PURPOSE


SODIUM FLUORIDE (NaF) 1.1% (w/v)               ANTICAVITY


INACTIVE INGREDIENTS


DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .

USE

USE: AIDS IN THE PREVENTION OF DENTAL DECAY IN PEDIATRIC PATIENTS AND ADULTS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR BRUSHING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   


ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Warnings

WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

PACKAGE LABEL

Neutra Maxx 5000PPM GEL  REFRESHING MINT FLAVOR


THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE  1.1% SODIUM FLUORIDE 5% POTASSIUM  NITRATE XYLITOL SLS FREE Rx ONLY.  NET WT 4.3 oz  (120 g)


MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS  GRAVETTE, AR 72736  THE MEDICINE AVAILABLE EXCLUSIVELY THROUGH YOUR DENTAL OFFICE. 

OTHER INFORMATION: STORE AT ROOM TEMPERATURE   QUESTION? COMMENTS? CALL 1-479-787-5168 M-F 9AM TO 5PM CST

Neutra Maxx 5000  sodium fluoride  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-504 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.428 g  in 120 g

Inactive Ingredients Ingredient Name Strength WATER   XYLITOL   POTASSIUM NITRATE   CARBOXYMETHYLCELLULOSE SODIUM   GLYCERIN   SODIUM PHOSPHATE   SACCHARIN SODIUM DIHYDRATE

Product Characteristics Color      Score      Shape Size Flavor MINT (Mint) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-504-06 120 g In 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

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

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

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals