Active Ingredient
Lidocaine 4%
Lidocare Patch
FDA Label NDC 69993-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Pharmaceuticals Dba Nfi, Llc for the product Lidocare (NDC 69993-400). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask doctor if, if pregnant or breast feeding, keep out of reach of children and pets, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Uses
For the temporary relief of pain.
Warnings
For external use only
When Using This Product
- use only as directed. Read and follow all directions and warnings on this package.
- do not allow contact with the eyes
- do not bandage or apply local heat (such as heating pads) to the area of use
- do not reuse patch
Stop Use And Ask Doctor If
- condition worsens
- rash, itching or skin irritation develops
- symptons persist for more than 7 days or clear up and occur again within a few days
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 Poison Control Center right away.
Instructions For Use
- clean and dry affected area
- cut open pouch and remove the patch
- remove clear protective liner from the patch
- apply to affected area no more than three (3) times per day
- leave patch in place for up to 8 but no more than 12 hours
- wash hands thoroughly after applying or removing patch
- some individuals may not experience pain relief until several minutes or hours after applying patch
- do not use other anesthetic products in addition to Lidocare
Storage Information
- protect from freezing or excessive heat
- store at 68°-77°F (20°-25°C)
Inactive Ingredients
Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether
Directions
Adults and Children over 12 years of age: Apply patch to affected area every 8 to 12 hours.
Children 12 years or younger: Consult a physician before use.
Package Label.Principal Display Panel
Lbl (Lidocare 3ct Back)
* Please review the disclaimer below.
