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Neutramaxx 5000 Plus Turbo Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Dec 11, 2022.

ACTIVE INGREDIENT SECTION

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: FILTERED WATER, SORBITAL, HYDRATED SILICA, GLYCERINE, XYLITOL, POTASSIUM NITRATE, MINT FLAVOR, PEG,CARBOXYMETHYLCELLULOSE, TITANIUM DIOXIDE, SODIUM SACCHARIN, DIMETHICONE, POLOXOMER 407

Indications and Usage for Neutramaxx 5000 Plus Turbo

INDICATIONS NEUTRAMAXXtm 5000 PLUS TURBO IS A SELF-APPLIED DENTIFRICE FOR PREVENTION OF TOOTH DECAY, ORTHODONTIC DECALCIFICATION AND HYPERSENSITIVITY

Warnings

DO NOT SWALLOW FOR TOPICAL USE ONLY AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

AS WITH ALL MEDICATIONS, KEEP OUT OF REACH OF CHILDREM

DIRECTIONS: USE AS DIRECTED

THIS PRESCRIPTION DENTIFRICE IS RECOMMENDED FOR ADULTS AND PEDIATRIC PATIENTS 6 YEARS AND OLDER.

APPLY A THIN RIBBON OF NEUTRAMAXXtm 500 PLUS TURBO ALONG THE LENGTH OF THE TOOTHBRUSH NO MORE THAN "PEA SIZE" TOTAL DOSE. BRUSH FOR 2 MINUTES

AFTER BRUSHING ADULTS-EXPECTORATE; DO NOT EAT OR DRINK FOR 30 MINUTES

CHILDREN 6 YEARS OF AGE OR OLDER-EXPECTORATE AND RINSE MOUTH WITH WATER

USE AT BEDTIME IN PLACE OF YOUR REGULAR TOOTHPASTE OR AS DIRECTED BY YOUR DENTAL PROFESSIONAL.

QUESTIONS? COMMENTS? SECTION

CALL 1-479-5168 M-F 9AM TO 5PM CST

PACKAGE LABEL

PROFESSIONAL CLEANING SYSTEM NEUTRAMAXXtm 5000 PLUS TURBO REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

1.1% NEUTRAL SODIUM FLUORIDE 5000PPM TOOTHPASTE WITH 5% POTASSIUM NITRATE SWEETENED WITH XYLITOL DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY NET WT. 4 OZ (112 G) NDC 63783-3233-112

MAUNFACTURES BY: MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, ar (479) 787-5168 WWW.MASSCODENTAL.NET

NEUTRAMAXX 5000 PLUS TURBO LABEL

NEUTRAMAXX 5000 PLUS TURBO
sodium fluoride paste
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63783-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g in 112 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
MINT (UNII: FV98Z8GITP)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLOXAMER 407 (UNII: TUF2IVW3M2)
Product Characteristics
Color Score
ShapeSize
FlavorMINT (MINT FLAVOR) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63783-323-01112 g in 1 TUBE; Type 0: Not a Combination Product09/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2011
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(63783-323)