Drug Facts
LIDOCAINE PATCH 4%
The following Structured Product Label (SPL) was submitted to the FDA by Simple Diagnostics for the product Pain Reliveing Patch (NDC 62379-201). 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 drug facts, active ingredient, purpose, use, warnings, when using this product, do not use:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
LIDOCAINE PATCH 4%
Lidocaine 4%
Topical anesthetic
For the temporary relief of pain
For external use only
Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor
Use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
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.
Ask a health professional before use
If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).
Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use.
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.
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