Your browser does not support JavaScript! NEUTRA MAXX 5000 (SODIUM FLUORIDE) GEL [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]
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NEUTRA MAXX 5000 (sodium fluoride) gel
[Massco Dental A Division of Dunagin Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 GEL LABEL

NEUTRA MAXX 5000 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63783-504
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE1.428 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
WATER 
XYLITOL 
POTASSIUM NITRATE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
SODIUM PHOSPHATE 
SACCHARIN SODIUM DIHYDRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-504-06120 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989
Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
NameAddressID/FEIBusiness Operations
Massco Dental A Division of Dunagin Pharmaceuticals008081858manufacture

Revised: 2/2012
 
Massco Dental A Division of Dunagin Pharmaceuticals

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