Lidocaine 4% Pain Relief Gel Patch

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Lidocaine 4% Pain Relief Gel Patch
Generic name
LIDOCAINE 4% PAIN RELIEF GEL PATCH
Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY
Product type
HUMAN OTC DRUG
SPL set ID
8e5a4ef4-b928-44b3-842c-92f1531af75b
SPL ID
ae454939-13c4-453d-a650-7a7f97d5893c
Version
1
Effective date
2025-03-03
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:18:46
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use: more than 1 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 at the same time as other topical analgesics When using this product: • use only as directed. • read and follow all directions and warnings on this label • rare cases of serious burns have been reported with products of this type. • do not apply to wounds or damaged, broken • eyes and mucous membranes • do not bandage tightly or apply local heat (such as • the same time as other topical analgesics • 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. • a transient burning sensation may occur upon application but generally disappears in several days • if a severe burning sensation occurs, discontinue use immediately. • discontinue use at least 1 hour before a bath or shower. • do not use immediately after a bath or shower. Stop use and ask doctor if: • condition worsen • 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 this product is applied if pregnant or breast feeding, 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 right away. Directions: Adult and children over 12years: Clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor Inactive ingredients: Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Butylated Hydroxytoluene, Polysorbate Other Information: Store at room temperature 20·25'C (68-77'F) Questions? call toll-free 1-844-912-4012

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.