481 - Lidocaine Pain Relief Patch

Manufacturer
Allegiant Health | InterMed Laboratories Private Limited
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:29:39

Label at a glance#

ProductLidocaine Pain Relief
Active ingredientLIDOCAINE
Label structure9 sections

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area carefully remove the backing from the patch starting at a corner Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours Discard patch after single use Children under 12 years of age: consult a physician.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use(s)

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use if you have

OTC - DO NOT USE SECTION

  • more than one patch on your body at a time
  • on cut 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
  • if pouch is damaged or opened

When using this product

OTC - WHEN USING SECTION

  • 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 bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of a used patch in a manner that always keeps the 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 ingest this patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions 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 an injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove the backing from the patch starting at a corner
  • Apply the sticky side of patch to the affected area.
  • Use one patch for up to 12 hours
  • Discard patch after single use

Children under 12 years of age: consult a physician.

Other information

SPL UNCLASSIFIED SECTION

  • store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine Pouch
Lidocaine Pouch
Lidocaine Carton
Lidocaine Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN6
1737778lidocaine 0.04 MG/MG Medicated PatchSCD6
1737778lidocaine 4 % Medicated PatchSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-481-07Lidocaine Pain Relief30 in 1 CARTONPATCH306
69168-481-07Lidocaine Pain Relief0.04 g in 1 PATCHPATCH0.046

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-48169168-481-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFAllegiant Health7f715144-f0c8-48fc-a22d-eac85759c66a2025-12-30WarningsExact identifier
ndc (package): 69168-481-07
ndc (product): 69168-481
ndc11 (package): 69168048107
spl id: 47327434-17b6-fcb6-e063-6294a90a232d
spl set id: 7f715144-f0c8-48fc-a22d-eac85759c66a

Reported adverse events (FAERS/openFDA)#

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