FDA Label for Ortho Guard
View Indications, Usage & Precautions
Ortho Guard Product Label
The following document was submitted to the FDA by the labeler of this product Massco Dental A Division Of Dunagin Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
ACTIVE INGREDIENT (IN EACH 10 ml)
SODIUM FLUORIDE 4.4 mg PURPOSE - ANTICAVITY
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
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