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| Product NDC Code | 81484-601 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain reliveing 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 | Anhui Miao De Tang Pharmaceutical Co., Ltd. | ||||
| 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.Lidocaine 4% 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.Adults and children 12 years of age and older: Wash and dry the affected area. Peel off the backing film from one side of the patch carefully Apply the exposed portion of the patch to the affected area. Gently press the patch with your hand to fit the affected area completely. Do not exercise vigorously during use to prevent the patch from falling off. Use only 1 patch for a maximum of 8 hours. Children under 12 years of age: Ask a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol. sodium polvacrylate, tartaric acid, poval, alcohol, 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.LIDOCAINE PATCH to help Temporarily relteves minor pain
Purpose
Information about the drug product’s indications for use.For the temporary relief of pain
Spl product data elements
Usually a list of ingredients in a drug product.Pain Reliveing Patch Lidocaine 4% LIDOCAINE LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) TARTARIC ACID METHYL ACRYLATE ALCOHOL WATER GLYCERIN POLYSORBATE 80 POLYVINYL ALCOHOL (18000 MW) SODIUM POLYACRYLATE (2500000 MW)
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.label
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.LIDOCAINE PATCH 4%
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.use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics dispose of used patch in manner that always keeps product away from children 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.
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(1-800-222-1222).
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.condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness or iritation develops you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics dispose of used patch in manner that always keeps product away from children 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. lf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.store at room temperature 15°-30°C (59°-86°F)
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.For external use only Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds for more than one week without consulting a doctor
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