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| Product NDC Code | 68400-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Gelato apf |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 245593, 656838 |
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| Labeler Name | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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.Dosage and administration: Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. 1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.
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.Indications and usage: A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Spl product data elements
Usually a list of ingredients in a drug product.Gelato APF Sodium Fluoride CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE WATER XANTHAN GUM XYLITOL FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SODIUM FLUORIDE FLUORIDE ION
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.LB.Gelato APF Gel_generic_R2.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Active ingredient: Purpose: Fluoride Ion 1.23% .................................Fluoride Treatment Gel Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Storage and handling
Information about safe storage and handling of the drug product.Other information: • Do not store above 25°C/77°F. Do not freeze.
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: Keep out of reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Read directions carefully before using.
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