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Pain relieving patch - Medication Information

Product NDC Code 84273-001
Drug Name

Pain relieving patch

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 4 g/1001
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 1737778
Application Number M017
Labeler Name Hunan En Pu Pharmaceutical Co., Ltd.
Packages
Package NDC Code Description
84273-001-01 5 bag in 1 box (84273-001-01) / 1 patch in 1 bag
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Lidocaine 4%

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 polyacrylate tartaric acid poval alcohol

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.
For the temporary relief of pain

Purpose

Information about the drug product’s indications for use.
Topical anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
Pain Relieving Patch Lidocaine 4% TARTARIC ACID PROPYLENE GLYCOL LIDOCAINE LIDOCAINE POLYVINYL ALCOHOL (18000 MW) ALCOHOL POLYACRYLIC ACID (250000 MW) SODIUM POLYACRYLATE (2500000 MW) GLYCERIN METHYL ACRYLATE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS POLYSORBATE 80 WATER

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

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.
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

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. lf swallowed, get medical help or contact a Poison Control Center 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.
condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness or irritation develops you experience signs of skin injury, such as pain, sweling, 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 only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. Used patches stll contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Storage and handling

Information about safe storage and handling of the drug product.
store at room temperature 15°-30C (59-86F).

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

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