Active Ingredients
Lidocaine 4%
Achelon Lidocaine Patch
FDA Label NDC 84209-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Achelon, Inc for the product Achelon Lidocaine Patch (NDC 84209-400). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use or 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
Purpose
Topical Analgesic
Uses
For the temporary relief of pain.
Warnings
For external use only.
Do Not Use
Do not use
- on raw or blistered skin
- on the eyes
- if alergic to lidocaine or any ingredient in the patch
- more than 4 daily
- with a heating pad
When Using This Product
- Use only as directed
- Do not inject through any patch material
Stop Use Or Ask A Doctor If
If you develop a rash or skin irritation
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
Adults and children 2 years of age or older:
- Apply the patch to clean dry skin 60 minutes before procedure
- Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area
- Follow usual needle procedure steps
- Remove ring after procedure
Children under 2 years of age:
Consult a doctor prior to use
Other Information
- store at 68 o - 77 o F (20 o - 25 o C)
Inactive Ingredients
Acrylic adhesive, Polyethylene film, Mylar release liner, Polyethylene Glycol, Levulinic acid, BrijL4LQ, Isopropyl Palmitate
Achelon Lidocaine 4%, One Patch In Indivdual Pouch
* Please review the disclaimer below.
