FDA.reportPublic FDA data

CVS Pain Relief Patch Lidocaine XL

Manufacturer
CVS Pharmacy
Effective date
2026-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-29 01:01:56

Label at a glance#

ProductCVS Pain Relief Lidocaine XL
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children 12 years and older: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area once applie...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

When using this product

OTC - WHEN USING SECTION

  • Use only as directed.
  • Read and follow all directions and warnings on this carton.
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds or damaged, broken or irritated skin
  • Do not allow contact with the eyes and mucous membrane
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not use at teh same time as other topical analgesics
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch
  • NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a physician before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and older: clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
  • once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
  • do not remove patch and reapply, this will result in the patch not sticking
  • avoid strenuous exercise while wearing patch, this will result in patch not sticking
  • do not use more than one patch in an 8 hour period. Maximum 3 patches per day.
  • Children 12 years or younger: ask a doctor.

Other information

OTHER SAFETY INFORMATION

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Principal Display Panel - 4 3/4 IN X 7 7/8 IN Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS TM

NDC 51316-286-03

XL

Maximum OTC Strength †

PAIN RELIEF

PATCH

LIDOCAINE

Lidocaine 4%

Compare to

Aspereme ® Lidocaine Patch

active ingredient ‡

Numbs Away Pain

Fast Acting

Targets Nerves

Fragrance Free

3 EXTRA-LARGE PATCHES

4 3/4 IN X 7 7/8 IN

(12 cm X 20 cm)

†Lidocaine concentration without a prescription,

among over-the-counter topical analgesics.

Each patch is sealed in a child-resistant pouch for safety.

XL Patch Carton LabelXL Patch Carton Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428130063GTIN-13: 0050428130063
EAN-13: 0050428130063
GTIN-12: 050428130063
UPC-A: 050428130063
GTIN storage (14 digits): 00050428130063		CT-YCSH-1282_385037_separated-1.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-28651316-286-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
POVIDONEFZ989GH94EIACT
KAOLIN24H4NWX5COIACT
PROPYLPARABENZ8IX2SC1OHIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM GLYCINATE1K713C615KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-12full-release2026-06-01 01:44:14

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
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsExact identifier
ndc (package): 51316-286-03
ndc (product): 51316-286
ndc11 (package): 51316028603
spl id: 59f3b521-b78b-eed1-e063-6294a90a0a08
spl set id: 4aa286e3-e274-8095-e063-6394a90ae871

Reported adverse events (FAERS/openFDA)#

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