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| Product NDC Code | 73557-157 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Pain relieving gel-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 | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | ||||||||
| Packages |
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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.Directions Adult and Children 12 years of age and over : Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age : Consult a doctor
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.Dosage forms & strengths This is a strip, patch dosage form. The active ingredient strength is 4% w/w. One patch one time, no more than 8 hours one time.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, 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 temporary relief of 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.Pain Relieving Gel-Patch Lidocaine POLYSORBATE 80 GLYCERIN POVIDONE K90 METHYLPARABEN PROPYLPARABEN EDETATE DISODIUM KAOLIN TARTARIC ACID WATER PROPYLENE GLYCOL POLYACRYLIC ACID (250000 MW) SODIUM POLYACRYLATE (2500000 MW) TITANIUM DIOXIDE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS LIDOCAINE LIDOCAINE
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 01 05 15 18
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 if: localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persists for more than 7 days Symptoms clear up and occur again within a few days
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 wounds or damaged skin With a heating pad If you are allergic to any ingredients of 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 Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1 646-223-0128 · [email protected]
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 if: localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persists for more than 7 days Symptoms clear up and occur again within a few days
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 Avoid contact with the eyes, mucous membranes or rashed Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy or breast feeding If pregnant or breastfeeding , ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information Avoid storing product in 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
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