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| Product NDC Code | 76162-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare pain relief 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 | 1249758 | ||||
| Application Number | part348 | ||||
| Labeler Name | Topco Associates 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 Lidocaine 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 and children 12 years of age and over: clean and dry affected area carefully remove backing from patch starting at a corner. Appli sticky side of patch to affected area. Use one patch for up to 12 hours Dispatch patch after a single use. children under 12 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, 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.Use for the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purposes Topical anesthetic Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.TopCare Pain Relief Patch Lidocaine, Menthol DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS SODIUM POLYACRYLATE (2500000 MW) POVIDONE, UNSPECIFIED GLYCERIN METHYLPARABEN KAOLIN POLYSORBATE 80 PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) TARTARIC ACID TITANIUM DIOXIDE PROPYLPARABEN WATER 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.Package/Label Principal Display Panel label
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 more than 1 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
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 and pets. If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.
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 Redness is present Irritation develops Symptoms persist 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
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.When using this product use only as directed Read and follow all directions and warnings on this carton Do not allow contact with the 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 use Do not microwave 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or 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
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