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| Product NDC Code | 82944-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocore (single unit 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 | Ion Pharma, 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 ingredients: 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, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to the skin (see illustration). Apply 1 patch at a time to affected area, not more than 3 to 4 times daily. Remove patch from the 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, Kaoloin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone 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.Uses: 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.LIDOCORE (single unit patch) Lidocaine 4% LIDOCAINE LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN KAOLIN METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL POLYACRYLIC ACID (450000 MW) POVIDONE K90 PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER
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 NDC 82944-103-01 LIDOCORE Lidocaine 4% Topical Anesthetic TOPICAL PAIN PATCH For Temporary Pain Relief Flexible Patch Innovation Soothing and Effective Long Lasting Relief 1 PATCH 5.5 x 3.94 (14cm x 10cm) APPLY FOR 8 HOURS ION PHARMA Lidocore
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 one patch on your body 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 reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: Avoid storing product in direct sunlight. Protect product from excessive moisture.
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: 833.711.8833 [email protected]
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 consult a doctor if: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering. Conditions worsen Symptoms persist 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 the eyes, mucous membranes or rashes Do not bandage tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: Ask a health professional before use.
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