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Ortho guard - Medication Information

Product NDC Code 63783-401
Drug Name

Ortho guard

Type Brand
Active Ingredients
Sodium fluoride 4.4 mg/10ml
Route ORAL
Dosage Form GEL, DENTIFRICE
Application Number M021
Labeler Name Massco Dental A Division of Dunagin Pharmaceuticals
Packages
Package NDC Code Description
63783-401-16 473 ml in 1 bottle (63783-401-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT (IN EACH 10 ml) SODIUM FLUORIDE 4.4 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients : Deionized water, monosodium phosphate, phosphoric acid, sodium benzoate, sodium saccharin, artificial coloring, artificial flavoring.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use Aids in the prevention of dental decay

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
ORTHO GUARD SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM BENZOATE SACCHARIN SODIUM ICY COOL MINT ORTHO GUARD SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM BENZOATE SACCHARIN SODIUM GRAPE ORTHO GUARD SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM BENZOATE SACCHARIN SODIUM STRAWBERRY

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 res massco__ortho_grape2 massco__ortho_mint2 massco__ortho_strawberry2

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP OUT OF REACH OF CHILDREN

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS? COMMENTS? CALL 1-479-787-5168 M-F 9 am TO 5pm CST

General precautions

Information about any special care to be exercised for safe and effective use of the drug.
OTHER INFORMATION Store at room temperature.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API