Lidocaine Pain Relief Patch
FDA Label NDC 57896-163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Lidocaine Pain Relief Patch (NDC 57896-163). 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, use, warnings, otc - pregnancy or breast feeding, keep out of reach of children and pets., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Topical Anesthetic

Use

Temporaily relieves minor pain.

Warnings

For external use only.

Do not us​e ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin
■ On puncture wounds ■ For more than one week without consulting a doctor
■ If you are allergic to any active or inactive ingredients
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 microwave
■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ 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.

Other Information

■ Store at room temperature ■ Avoid direct sunlight ■ Protect from excessive moisture

Inactive Ingredients

aluminum glycinate, benzyl alcohol, butylated hydroxyanisole, carboxymethylcellulose sodium,
edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid,
phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol, PVP, sodium
polyacrylate, sorbitol, tartaric acid, titanium dioxide, water

Questions Or Comments:

Call 1-800-540-3765

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