FDA Label for Neutra Maxx 5000
View Indications, Usage & Precautions
Neutra Maxx 5000 Product Label
The following document was submitted to the FDA by the labeler of this product Massco Dental A Division Of Dunagin Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.