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Name:Neutra Maxx 5000
Manufacturer:Massco Dental A Division Of Dunacin Pharmaceuticals
Category:Prescription Marketed Drugs


NEUTRA MAXX 5000  - sodium fluoride gel 
Massco Dental A Division of Dunacin Pharmaceuticals

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.

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ACTIVE INGREDIENTS

ACTIVE INGREDIENT                                      PURPOSE

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

INACTIVE INGREDIENTS

DISTILLED WATER, GLYCERINE, SODIUM SACCHARIN, SODIUM PHOSPHATE MONOBASIC, POTASSIUM PHOSPHATE DIBASIC, NATROSOL

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 5000PPMGEL

THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE  1.1% SODIUM FLUORIDE 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. 

NEUTRA MAX GEL LABEL


NEUTRA MAXX 5000 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
POTASSIUM PHOSPHATE, DIBASIC  
GLYCERIN  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC: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: 10/2010 Massco Dental A Division of Dunacin Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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