Label: NEUTRAMAXX 5000 PLUS TURBO- sodium fluoride paste
- NDC Code(s): 63783-500-04
- Packager: Massco Dental A Division of Dunagin Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 17, 2023
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT SECTION
- INACTIVE INGREDIENT SECTION
- INDICATIONS SECTION
- WARNINGS SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
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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.
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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
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INGREDIENTS AND APPEARANCE
NEUTRAMAXX 5000 PLUS TURBO
sodium fluoride pasteProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 1.1 g in 112 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT (MINT FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-500-04 112 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2011 Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Business Operations Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture(63783-500)