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Product NDC Code | 10882-529 | ||||||||
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Drug Name | Lidopatch pain relief |
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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 | JAR Laboratories | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Lidocaine HCL 4% Menthol 1%
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: 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 Ingredients Dihydroxyaluminium Aminoacetate,Disodium EDTA,Glycerine ,Sopropyl Myristate, Methylparaben,Polysorbate 80,Polyvinyl Alcohol,Propylene Glycol,Propylparaben, Sodium Carboxymethyl Cellulose,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 Analgesic Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.LidoPatch Pain Relief Lidocaine hcl, Menthol PROPYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM POLYACRYLATE (2500000 MW) TITANIUM DIOXIDE PROPYLENE GLYCOL POLYVINYL ALCOHOL, UNSPECIFIED WATER METHYLPARABEN EDETATE DISODIUM GLYCERIN TARTARIC ACID DIHYDROXYALUMINUM AMINOACETATE POLYSORBATE 80 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.3ct box outer box label label label 2
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions? Email [email protected] or call 866-284-2948
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 if you are allergic or sensitive to lidocaine or menthol. Do not reuse, apply to intact skin only. Do not use if pouch is damaged or opened. Handling and Disposal hands should be washed after the handling and eye contact should be avoided do not store patch outside the sealed pouch apply immediately after removal from protective pouch fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get them kept out of the reach of children both before and after use Stop use and ask a doctor if excessive redness or irritation is present condition worsens pain persists for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding , ask a health professional before use.
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