Active Ingredients
Lidocaine 4%
Lidotrode Patch
FDA Label NDC 83295-6400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strand Health Group for the product Lidotrode (NDC 83295-6400). 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, allergy alert, do not use, when using this product, stop use and ask doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Uses
For the temporary relief of muscle pain and joint pain associated with:
-Backache -Neckache -Cramps -Soreness -Strains -Discomfort
Allergy Alert
Local anesthetics may cause methemoglobinemia. If an allergic reaction occurs, stop use and seek medical attention immediately.
Do Not Use
-On damaged, irritated, or infected skin
-If you are allergic to any ingredients in this product
-Otherwise as directed
When Using This Product
Avoid contact with the eyes, nose, and mouth
Stop Use And Ask Doctor If
-Any of the warnings apply to you
-Excessive skin irritation develops
-Condition worses
If Pregnant Or Breastfeeding
Ask a healthcare professional before use
Keep Out Of Reach Of Children
If ingested, seek medical help or contact Poison Control immediately
Flammable
Keep away from excessive heat or open flame
Directions
Adults and Children 12 Years of Age and Older:
-Clean and dry the affected area
-Apply gel pads directly to the skin for up to 12 hours
-One application of 4 pads per-day is recommended
-Wash hands immediately after use
Other Information
-Store in a cool, dry place with pouch tightly sealed. Keep from freezing.
Inactive Ingredients
Aloe, Arnica, Magnesium, Polyacrylate, Vegan Glycerol
Questions Or Comments
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