Active Ingredient
ACTIVE INGREDIENT (IN EACH 10 ml)
SODIUM FLUORIDE 4.4 mg PURPOSE - ANTICAVITY
Ortho Guard Gel, Dentifrice
FDA Label NDC 63783-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Massco Dental A Division Of Dunagin Pharmaceuticals for the product Ortho Guard (NDC 63783-403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, use, keep out of reach of children, directions for use, other information, questions ? comments ?, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
INACTIVE INGREDIENTS: DEMINERALIZED WATER, MONOSODIUM PHOSPHATE, SODIUM BENZOATE, SODIUM SACCHARIN, ARTIFICIAL COLORING, ARTIFICIAL FLAVORING
Use
AIDS IN THE PREVENTION OF DENTAL DECAY
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Directions For Use
ADULTS AND CHILDREN 6 YEARS AND OLDER
USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE. VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING. INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.
CHILDREN UNDER 6
CONSULT A DENTIST OR PHYSICIAN
Other Information
STORE AT ROOM TEMPERATURE
Questions ? Comments ?
QUESTIONS? COMMENTS? CALL 1-479-787-5168 M-F 9 am TO 5pm CST
Warnings
WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.
IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR RINSING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Package Label
ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION. MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168. WWW.MASSCODENTAL.NET
Ortho Mint (Massco Ortho Mint2)
Ortho Orange (Massco Ortho Orange2)
Ortho Strawberry (Massco Ortho Strawberry2)
Ortho Grape (Massco Ortho Grape2)
* Please review the disclaimer below.
