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| Product NDC Code | 55758-040 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Parche de leon |
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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 | 1249758 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Pharmadel LLC | ||||||
| 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 Ingredients & Purpose Active ingredients (in each patch) Purpose Lidocaine 4% ................. External analgesic Menthol 1% .................... External analgesic
| Lidocaine 4% ................. | External analgesic |
| 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 & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor - clean dry affected area - remove patch from film - apply sticky side of patch to affected area - use one patch at a time - leave patch on affected area for up to 8-hours at a time
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients dihydroxyaluminum aminoacetate anhydrous, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, propylene glycol, povidone k90, 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.
Purpose
Information about the drug product’s indications for use.Active ingredients (in each patch) Purpose Lidocaine 4% ................. External analgesic Menthol 1% .................... External analgesic
| Lidocaine 4% ................. | External analgesic |
| Menthol 1% .................... |
Spl product data elements
Usually a list of ingredients in a drug product.Parche de Leon Lidocaine, Menthol EDETATE DISODIUM PROPYLENE GLYCOL WATER DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS POVIDONE K90 KAOLIN POLYSORBATE 80 POLYACRYLIC ACID (800000 MW) TITANIUM DIOXIDE GLYCERIN SODIUM POLYACRYLATE (8000 MW) TARTARIC ACID HYDROXYACETOPHENONE MINERAL OIL LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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.Principal Display Panel 5 Patches (5.5 in x 3.94 in (13.97 cm x 10 cm) each) Maximum Strength Fast Acting pain relief PDP Parche
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.Drug Facts Active Ingredients & Purpose Active ingredients (in each patch) Purpose Lidocaine 4% ................. External analgesic Menthol 1% .................... External analgesic
| Lidocaine 4% ................. | External analgesic |
| Menthol 1% .................... |
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.Do not use in large quantities, particularly over raw surfaces or blistered areas on sensitive skin if allergic to any ingredients in this product
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.Other Information store at room temperature 59-86 F (15-30 C) do not store in direct sunlight or expose to excessive heat TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken.
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 ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of breast-feeding ask a health professional before use.
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 . Avoid contact with the eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas on sensitive skin if allergic to any ingredients in this product Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present If pregnant of breast-feeding 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.
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