Drug Facts
LIDOCAINE PATCH 4%
Pain Reliveing Patch
FDA Label NDC 62379-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
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, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine 4%
Purpose
Topical anesthetic
Use
for the temporary relief of pain
Warnings
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
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 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.
Stop Use And Ask A Doctor If
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness or iritation develops you experience signs of skin injury, such as pain, swelling, or blistering where
the product was applied
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).
Directions
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.
Other Information
store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredient
dihydroxyaluminum aminoacetate anhydrous, propylene glycol, polyacrylic acid, tartaric acid, methyacrylate, alcohol, water, glycerin, polysorbate 80, polyvinyl alcohol, sodium polyacrylate
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