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| Product NDC Code | 62379-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain reliveing 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 | simple diagnostics | ||||
| 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 Adults and children 12 years of age and older: Wash and dry the affected area. Peel off the backing film from one side of the patch carefully Apply the exposed portion of the patch to the affected area. Gently press the patch with your hand to fit the affected area completely. Do not exercise vigorously during use to prevent the patch from falling off. Use only 1 patch for a maximum of 8 hours. Children under 12 years of age: Ask a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, 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.USE For the 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 Reliveing Patch Lidocaine 4% KAOLIN PROPYLPARABEN POVIDONE K90 EDETATE DISODIUM METHYLPARABEN TITANIUM DIOXIDE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) TARTARIC ACID WATER GLYCERIN POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) LIDOCAINE LIDOCAINE
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. PRINCIPAL DISPLAY PANEL: Pack of 30 Pouches Pack of 5 Pouches Pouch
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 LIDOCAINE PATCH 4%
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 right away(1-800-222-1222).
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: [email protected] 877-342-2385
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 IF: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Condition worsen 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. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 15°-30°C (59°-86°F) Store in a cool dry place away from direct sunlight
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 Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds for more than one week without consulting a doctor
DO NOT USE: More than 1 patch at a time On wounds or damaged skin For more than one week without consulting a doctor If you are allergic to any ingredients of this product
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