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| Product NDC Code | 69396-134 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief gel-patch |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1737778 | ||||
| Application Number | M017 | ||||
| Labeler Name | Trifecta Pharmaceuticals USA, LLC. | ||||
| 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 Lidocaine 4%
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 Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from teh skin after at most 8-hour application Children under 12 years of age. Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.
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.For temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief Gel-Patch Lidocaine 4% POLYACRYLIC ACID (8000 MW) POLYSORBATE 80 TARTARIC ACID METHYLPARABEN SODIUM POLYACRYLATE (8000 MW) TITANIUM DIOXIDE WATER GLYCERIN PROPYLENE GLYCOL LIDOCAINE LIDOCAINE KAOLIN EDETATE SODIUM POVIDONE K90 PROPYLPARABEN DIHYDROXYALUMINUM AMINOACETATE
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.4802 Globe Lidocaine Patch 101323 CDER
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.Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com SKU: 4802
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 1 patch at a time On wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product
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 the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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 1-888-296-9067
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering Condition worsens Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days
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 Use only as directed Avoid contact with eyes, mucous membranes or rashes Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or Breast-Feeding Ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 68º-77ºF (20º-25ºC) Avoid storing product in direct sunlight Protect product from excessive moisture
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
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