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Product NDC Code | 85212-0004 | ||||
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Drug Name | Arthcal 4% lidocaine patches |
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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 | EXTRACORPOREAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 1737778 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Beijing JUNGE Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Lidocaine 4.0% Purpose 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.DRUG FACTS
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone 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.DIRECTIONS Adults and children 12 years of age and over: clean and dry affected area apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove film from patch and apply to the skin Children under 12 years of age: consult a doctor
Purpose
Information about the drug product’s indications for use.USE For temporary relief of pain
Spl product data elements
Usually a list of ingredients in a drug product.Arthcal 4% Lidocaine Patches Lidocaine WATER GLYCERIN PROPYLPARABEN LIDOCAINE LIDOCAINE POLYSORBATE 80 DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS TARTARIC ACID TITANIUM DIOXIDE POVIDONE K90 KAOLIN PROPYLENE GLYCOL METHYLPARABEN
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.4% Lidocaine Patches
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.QUESTIONS? 1-888-655-1558
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.OTHER INFORMATION store in a clean, dry place outside of direct sunlight, Protect product 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 1 patch at a time with a heating pad on wounds or damaged skin ir you are allergic to any ingredients of this product When using this product use only as directed do not bandage tightly avoid contact with the eyes, mucous membranes or rashes Stop use and ask a doctor if symptoms persist for more than 7 days conditions worsen symptoms clear up and occur again within a few days localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop If pregnant or 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