Lidocaine 4% Pain Relief Gel Patch
FDA Label NDC 55629-024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Lidocaine 4% Pain Relief Gel Patch (NDC 55629-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use:, when using this product:, stop use and ask doctor if:, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Use

Temporarily relieves minor pain

Warnings

For external use only

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
  • at the same time as other topical analgesics

When Using This Product:

• use only as directed.
• read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type.
• do not apply to wounds or damaged, broken
• eyes and mucous membranes
• do not bandage tightly or apply local heat (such as
• the same time as other topical analgesics
• 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.
• a transient burning sensation may occur upon application but generally disappears in several days
• if a severe burning sensation occurs, discontinue use immediately.
• discontinue use at least 1 hour before a bath or shower.
• do not use immediately after a bath or shower.

Stop Use And Ask Doctor If:

• condition worsen
• 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 this product is applied

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children And Pets

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and
  • gently pulling until back separates in middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of
  • patch to affected area 
  • use 1 patch for up to 12 hours
    • children 12 years or younger: ask a doctor

Inactive Ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate

Other Information:

Store at room temperature 20·25'C (68-77'F)

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