Loxyine
FDA Label NDC 83658-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sj Incorporation Ltd for the product Loxyine (NDC 83658-011). 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, uses, warnings, do not use, when using this product, stop use and ask a 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 4.0%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

Do Not Use

  • more than one 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
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.

When Using This Product

  • use only as directed
  • Read and follow all directions and warning on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage only tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always 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.

Stop Use And Ask A Doctor If

  • Condition worsens
  • 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 or skin injury, such as pain, swelling or blistering where the product was applied. 

If Pregnant Or Breast-Feeding,

ask a healthcare professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one path for up to 12 hours. Discard patch after single use. 

Children under 12 years of age: Consult a physician.

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water. 

Questions Or Comments?

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