Active Ingredients
Lidocaine HCL 4%
Menthol 1%
Lidopatch Pain Relief Patch
FDA Label NDC 10882-529
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jar Laboratories for the product Lidopatch Pain Relief (NDC 10882-529). 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, indications & usage, warnings, directions, otc - keep out of reach of children, inactive ingredients, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Indications & Usage
For temporary relief of pain.
Warnings
For external use only. Do not use if you are allergic or sensitive to lidocaine or menthol. Do not reuse, apply to intact skin only. Do not use if pouch is damaged or opened.
Handling and Disposal
- hands should be washed after the handling and eye contact should be avoided
- do not store patch outside the sealed pouch
- apply immediately after removal from protective pouch
- fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get them
- kept out of the reach of children both before and after use
- excessive redness or irritation is present
- condition worsens
- pain persists for more than 7 days
- symptoms clear up and occur again within a few days
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Directions
- adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
- children: consult your physician
- remove protective film, gently apply to affected area
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Dihydroxyaluminium Aminoacetate,Disodium EDTA,Glycerine ,Sopropyl Myristate, Methylparaben,Polysorbate 80,Polyvinyl Alcohol,Propylene Glycol,Propylparaben, Sodium Carboxymethyl Cellulose,Sodium Polyacrylate Tartaric Acid,Titanium Dioxide,
Water
Other Safety Information
Questions? Email [email protected] or call 866-284-2948
Package Label.Principal Display Panel
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Label (Label)
outer box label
Label 2 (Label.2png)
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