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| Product NDC Code | 63783-403 | ||||
|---|---|---|---|---|---|
| Drug Name | Ortho guard |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| Application Number | M021 | ||||
| Labeler Name | Massco Dental A Division of Dunagin Pharmaceuticals | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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