Active Ingredient
Lidocaine 4.0%
Healthwise Flexible 4% Lidocaine Patch
FDA Label NDC 71101-081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Flexible 4% Lidocaine Patch (NDC 71101-081). 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 consult a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
Temporarily relief of pain.
Warnings
For External Use Only
Do Not Use
■over raw surfaces or blistered areas
When Using This Product
■ Avoid contact with the eyes
■ Do not use more than one patch on your body at a time
Stop Use And Consult A Doctor If
■ skin Irritation develops
■ Condition worsens
■ Symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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 (1-800-222-1222) right away.
Directions
Directions
■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discard patch after single use.
■ Children under 2 years of age: Do not use, ask a doctor
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 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.
Inactive Ingredients
hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer
* Please review the disclaimer below.
