Skip to main content

Neutra Maxx Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: oral gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Dec 25, 2022.

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.

Indications and Usage for Neutra Maxx

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 DRUGItem Code (Source)NDC:63783-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.428 g in 120 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
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; Type 0: Not a Combination Product01/01/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/198912/31/2023
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(63783-504)

Medical Disclaimer