Active Ingredient
Lidocaine 4.0%
Healthwise Pain Relief Lidocaine Patch
FDA Label NDC 71101-058
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 Pain Relief Lidocaine Patch (NDC 71101-058). 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
Topical Anesthetic
Use
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
■ Over raw surfaces or blistered areas
■ 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 warnings on this carton
■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics
■ Do not bandage 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 Consult 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 of skin injury, such as pain, swelling or blistering where the product was applied.
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
Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch for up to 24 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, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin,
petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium
polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol
* Please review the disclaimer below.
