Active Ingredient
Lidocaine 4.0%
Theracare Pain Relief Patch
FDA Label NDC 71101-108
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 Theracare Pain Relief Patch (NDC 71101-108). 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, 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
External analgesic
Use
For temporary 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
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 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 12 hour period. Maximum 2 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
aluminum glycinate, benzyl alcohol, butylated hydroxy anisole, carboxymethylcellulose sodium, edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid, phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, povidone,
propylene glycol, sodium polyacrylate, sorbitol, tartaric acid, titanium dioxide, water
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