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| Product NDC Code | 85839-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Lidocaine 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 | ||||
| Application Number | M017 | ||||
| Labeler Name | Shenzhen Finona Information Technology Co., Ltd | ||||
| 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.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.Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area.Use one patch for up to 12 hours. Discard patch aftersingleuse. Children under 12 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aluminum Glycinate Aluminum Hydroxide Cellulose Gum DMDM hydantoin Glycerin Polyacrylic Acid Polysorbate 80 Propylene Glycol Ricinus Communis Seed Oil (castor) Silica Sodium Polyacrylate Tartaric Acid Titanium Dioxide Urea 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.Temporarily relieves minor pain
Purpose
Information about the drug product’s indications for use.Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Patch Lidocaine LIDOCAINE LIDOCAINE ALUMINUM GLYCINATE ALUMINUM HYDROXIDE CELLULOSE GUM DMDM HYDANTOIN GLYCERIN PROPYLENE GLYCOL SILICA SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE POLYSORBATE 80 POLYACRYLIC ACID (250000 MW) RICINUS COMMUNIS (CASTOR) SEED OIL WATER UREA
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.label7
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.More than one patch on your body at a time On cut, initated or swollen skin Onpuncture wounds. For more than one week without consulting a doctor lf you are allergicto any active or inactive ingredients lf pouch is damaged or opened.
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
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, Condition worsens,Redness is present lrritationdevelops Symptoms persist for more than 7 days or clear up and occur again within afew days You experience signs of skin injury, such as pain, swelling or blistering wherethe product was applied.
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 alldirections and waringson this carton Do not allow contact with the eyes. Do not use at the same time as othertopical analgesics Do not bandage tightly orapply local heat (such as heating pads) to thearea of use Dispose of usedpatch inmanner that always keeps product away from childrenand pets, Used patches stil contain the drug product that can produce serious adverse effectsifa child or pet chews or ingests this patch.
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.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