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| Product NDC Code | 55264-106 | ||
|---|---|---|---|
| Drug Name | Sinsinpas lidocaine pain relieving |
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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 | TRANSDERMAL | ||
| Dosage Form | PATCH | ||
| RxCUI drug identifier | 1737778 | ||
| Application Number | M017 | ||
| Labeler Name | Sinsin Pharmaceutical Co., Ltd | ||
| 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 Lidocaine 4% 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.Do not use more than 1 patch at a time on broken, irritated, or swollen skin on puncture wounds for more than one week without consulting a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients butylated hydroxytoluene, carboxymethylcellulose sodium, Concentrated Glycerin, Disodium edetate Hydrate isopropyl myristate, kaolin, magnesium aluminosilicate, Nikazole TS-620, methyl paraben, polyacrylic acid solution, polysorbate 80, propylene glycol, propyl paraben, purified water, sodium polyacrylate, sorbitan sesquioleate, tartaric acid, titanium dioxide, urea, D-sorbitol solution,
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 temporary relief of minor pain
Purpose
Information about the drug product’s indications for use.Purpose Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.SINSINPAS LIDOCAINE PAIN RELIEVING lidocaine LIDOCAINE LIDOCAINE ISOPROPYL MYRISTATE BUTYLATED HYDROXYTOLUENE GLYCERIN
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.SINSINPAS MAXIMUM STRENGTH LIDOCAINE 4% PAIN RELIEVING PATCH TARGETS PAIN FOR QUICK RELIEF PERETRATES NERVE RECEPTORS TO NUMB AND DESENSITIZE LONG LASTING AND UNSCENTED EASY TO APPLY 5 PATCHES 3.93 IN X 5.51 IN, EACH ODOR FREE SINSINPAS LIDOCAINE PAIN RELIEF PATCH
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.Ask a doctor Children under 12 years of age: consult a healthcare professional
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 at a time on broken, irritated, or swollen skin on puncture wounds for more than one week without consulting a doctor
Instructions for use
Information about safe handling and use of the drug product.Uses For temporary relief of minor pain
Directions Adults/children 12 years of age and over clean and dry affected area remove film from patch by gently pulling apart from corner carefully apply to affected area once patch is positioned, press firmly to adhere to skin use only one patch at a time for up to 12 hours
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 or pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information avoid storing in direct sunlight protect product from excess moisture store at room temperature. Do not exceed 86° Fahrenheit, 30° Celsius
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 irritation develops redness is present symptoms persist for more than 7 days or clear up and occur again within a few days any signs of skin injury appear at the site of the product application such as pain, swelling, bruising, or blistering
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 label Avoid contact with the eyes or mucous membranes - Do not apply to broken, damaged, or irritated skin Do not bandage tightly or apply local heat (such as heating pads) to the area of use Rare cases of serious burns have been reported with products of this type Do not use with other topical analgesics Keep children and pets away from used or disposed patch. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a physician 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