Otc - Active Ingredient
ACTIVE INGREDIENT (IN EACH 10 ml)
SODIUM FLUORIDE 4.4 mg
Ortho Guard Gel, Dentifrice
FDA Label NDC 63783-401
10 label sections · Submitted to the FDA by Massco Dental A Division Of Dunagin Pharmaceuticals · 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 63783-401). 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 otc - active ingredient, otc - purpose, inactive ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, general precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anticavity
Inactive Ingredient
Inactive Ingredients: Deionized water, monosodium
phosphate, phosphoric acid, sodium benzoate, sodium
saccharin, artificial coloring, artificial flavoring.
Indications & Usage
Use
Aids in the prevention of dental decay
Warnings
Warnings
- When using this product, do not swallow unless 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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Dosage & Administration
DIRECTIONS: Use As Directed
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
General Precautions
OTHER INFORMATION
- Store at room temperature.
Otc - Questions
QUESTIONS? COMMENTS?
CALL 1-479-787-5168 M-F 9 am TO 5pm CST
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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