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Product NDC Code | 73352-520 | ||||
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Drug Name | Tridergel |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1049228, 2671305 |
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Application Number | M005 | ||||
Labeler Name | Trifluent Pharma LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzalkonium Chloride (0.1%)
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 Clean the wound before each application Apply a thin layer of Tridergel™ wound care gel to the wound surface and skin immediately surrounding the wound Cover the wound as directed by your physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice Extract, Aminomethyl Propanol, Butylparaben, Carbomer, Decyl Glucoside, Ethylparaben, Glycerin, Hydrolyzed Eggshell Membrane, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sodium Hyaluronate.
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 for management of: Stage 1-2 open wounds Superficial stasis ulcers Superficial diabetic skin ulcers Post-surgical incisions First and second-degree burns Cuts Abrasions and skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Tridergel Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER EGG SHELL MEMBRANE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN AMINOMETHYLPROPANOL HYALURONATE SODIUM ALOE VERA LEAF PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN BUTYLPARABEN PROPYLPARABEN
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.PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label TRIFLUENT PHARMA ® TRIDERGEL™ WOUND CARE GEL BENZALKONIUM CHLORIDE IN A GEL CONTAINING TRANSFORMING GROWTH FACTOR – β NDC 73352-520-01 1.0 FL OZ (29.6 mL) PRODUCT SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A LICENSED MEDICAL PRACTITIONER PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label
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.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use more than the recommended dose or longer than prescribed without checking with your physician . Talk with your physician before you use any other medicines or cleansers on your skin. Ask your physician before prolonged sun exposure. If your symptoms do not improve or they worsen, contact your physician
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 . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS CALL (210) 944-6920
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.
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 For external use only. When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs. Do not use more than the recommended dose or longer than prescribed without checking with your physician . Talk with your physician before you use any other medicines or cleansers on your skin. Ask your physician before prolonged sun exposure. If your symptoms do not improve or they worsen, contact your physician Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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