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| Product NDC Code | 83035-1133 | ||||
|---|---|---|---|---|---|
| Drug Name | True lido 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 | Singular Dreamer, Ltd dba True Marker | ||||
| 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 Purposes Lidocaine 4.00% .....................................................Topical Anesthetic
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 Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin 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, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, 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 the temporary relief of pain.
Spl product data elements
Usually a list of ingredients in a drug product.True Lido Patch Lidocaine DIHYDROXYALUMINUM AMINOACETATE EDETATE DISODIUM GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 POVIDONE K90 PROPYLENE GLYCOL PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER 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 at controlled room temperature 20° - 25°C (68° - 77°F) Avoid storing product in direct sunlight Protect product from excessive moisture
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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 1 patch at a time ● On wounds or damaged skin ● With a heating pad ● If you are allergic to any ingredients of this product When using this product : ● Use only as directed ● Avoid contact with eyes, mucous membranes or rashes ● Do not bandage tightly Stop use and ask a doctor if : ● Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering ● Condition worsen ● Symptoms persist 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. Keep out of the reach of children . 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