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| Product NDC Code | 10882-527 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lidopatch |
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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 | 1739875, 1792852 |
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| Application Number | M017 | ||||||||
| Labeler Name | J.A.R. Laboratories | ||||||||
| 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 SECTION Lidocaine HCL 3.6% - Topical analgesic Menthol 1.25% - Topical analgesic
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.DOSAGE & ADMINISTRATION SECTION Directions: Aduts apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours. children : consult your physician remove protective film, gently apply to affected area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION Dihydroxyaluminum aminoacetate, Disodium EDTA, Glycerine, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Propyl paraben, Sodium, Carboxymethylcellulose, 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.Usage Aduts apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours
Purpose
Information about the drug product’s indications for use.PURPOSE Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle straints, sprains and bruises.
Spl product data elements
Usually a list of ingredients in a drug product.Lidopatch lidocaine, menthol WATER PROPYLENE GLYCOL PROPYLPARABEN SODIUM POLYACRYLATE (8000 MW) POLYVINYL ALCOHOL, UNSPECIFIED CARBOXYMETHYLCELLULOSE GLYCERIN POLYSORBATE 80 DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM ANHYDROUS METHYLPARABEN TARTARIC ACID TITANIUM DIOXIDE ISOPROPYL MYRISTATE LIDOCAINE LIDOCAINE MENTHOL MENTHOL
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 LABEL
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.
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 SECTION Stop Use and ask doctor if: excessive redness or irritation is present Pain persists for more than 7 days symptoms cear up and occur again within a few days conditions worsens If pregnant or breasfeading, ask a health professional before use. keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
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 SECTION For external use only. Do not use if you are allergic or sensitive to lidocaine or menhol. Do not use if pouch is damaged or opened.
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