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Neutra Maxx

Generic name: sodium fluoride
Dosage form: oral gel

Medically reviewed by Drugs.com. Last updated on Jan 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 LABEL 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
XYLITOL
POTASSIUM NITRATE
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
SODIUM PHOSPHATE
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor MINT (Mint) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:63783-504-06 120 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/1989
Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858)
Establishment
Name Address ID/FEI Operations
Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture(63783-504)
Massco Dental A Division of Dunagin Pharmaceuticals