FDA.reportPublic FDA data

CVS Health XL Lidocaine Pain Relief

Manufacturer
NATURAL ESSENTIALS, INC. | Foshan Aqua Gel Biotech, Co., Ltd.
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

ProductCVS Health XL Lidocaine Pain Relief
Active ingredientLidocaine
Label structure10 sections

Dosage and administration

Adults/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, pr...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

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 or 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.
  • Do not use more than one patch in an 8 hour period. Maximum 3 patches per day.
  • 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 membranes
  • 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 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
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding ask a physician before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults/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.

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, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Principal Display Panel – 858 mg Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription‡

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical Anesthetic

Odor free

  • Desensitizes
    aggravated nerves
  • Fast acting
  • Easy to apply
  • No irritation
    or burning

‡ Among over-the-counter
topical analgesics

3 PATCHES

4 3/4 IN X 7 7/8 IN (12 cm X 20 cm)

Pain-relieving ointment on a breathable adhesive pad

EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY.

71 %
LARGER

Principal Display Panel – 858 mg Box Label
Principal Display Panel – 858 mg Box Label

Principal Display Panel – 858 mg Patch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical Anesthetic

Odor free

  • Desensitizes
    aggravated nerves
  • Fast acting
  • Easy to apply
  • No irritation
    or burning

1 PATCH

4 3/4 IN X 7 7/8 IN
(12 cm X 20 cm)

Pain relieving ointment on a breathable adhesive pad

†Among over-the-counter
topical analgesics

Principal Display Panel – 858 mg Patch Label
Principal Display Panel – 858 mg Patch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN7
1737778lidocaine 0.04 MG/MG Medicated PatchSCD7
1737778lidocaine 4 % Medicated PatchSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-286-03CVS Health XL Lidocaine Pain Relief1 in 1 PATCHPATCH17
66902-286-03CVS Health XL Lidocaine Pain Relief3 in 1 BOXPATCH37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-286CVS HEALTH XL LIDOCAINE PAIN RELIEF (LIDOCAINE) PATCH [NATURAL ESSENTIALS, INC.]7Current NDC, Legacy NDC, 2 package rows20240119_ec16da91-8244-402b-b8d8-84896094ac2c.zip

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
66902-28666902-286-03

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
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
POVIDONE K90RDH86HJV5ZIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
CVS Health XL Lidocaine Pain ReliefLIDOCAINENATURAL ESSENTIALS, INC.ec16da91-8244-402b-b8d8-84896094ac2c2024-01-17WarningsExact identifier
ndc (package): 66902-286-03
ndc (product): 66902-286
ndc11 (package): 66902028603
spl id: 393e79bf-a2d5-4a6c-97b0-dbf787ecb547
spl set id: ec16da91-8244-402b-b8d8-84896094ac2c

Reported adverse events (FAERS/openFDA)#

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