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| Product NDC Code | 82728-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Manamed lidocaine 4% pain relieving gel 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 | Manamed, Inc. | ||||
| 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 over: Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.Use one patch for up to 8 hrs Children under 12 years of age : consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Propylene Glycol, PVP, Sodium Polyacrylate, Methylparaben, Propylparaben, Aluminum Glycinate, Kaolin, Polyacrylic Acid, Polysorbate 80, Tartaric Acid, Titanium Dioxide
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 Temporarily relieves minor 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.ManaMed Lidocaine 4% Pain Relieving Gel Patch Lidocaine WATER GLYCERIN PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN KAOLIN POLYSORBATE 80 TARTARIC ACID TITANIUM DIOXIDE POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (8000 MW) POLYACRYLIC ACID (8000 MW) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS 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.Product label image description image description
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.Other information Store in clean, dry place outside of direact sunlight. Protect from excessive moisture.
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 one patch on your body at a time On cut, irritated or swollen skin On puncture wounds For more than one week without consulting a doctor If you are allergic to any active or inactive ingredients If pouch is damaged or opened When using is product Use only as direacted Read and follow all direactions and warnings on this carton Do not allow contact with eyes Do not use at the same time as other topical analgesics Do not bandage tightly or apply local heat (such as heating pads)to the area of the use Do not microwave Dispose of used patch in the manner that always keeps product away from childen 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. Stop use and consult a doctor if Condition worsens Redness is present Irritation develops Symtoms persists for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied. If pregnant or breastfeading , ask health professional before use. Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.
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