FDA.reportPublic FDA data

CVS Health 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 00:08:18

Label at a glance#

ProductCVS Health 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 – 567 mg Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

Compare to the active ingredient
in Aspercreme® Lidocaine Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine Pain
Relief Patch

LIDOCAINE 4%

Topical Analgesic

Odor Free

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

Package Contains 5 Individually
Wrapped Patches

5 PATCHES

3 15/16 IN X 5 ½ IN (10 cm X 14 cm)

Pain-relieving ointment on a breathable adhesive pad

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

†Among over-the-counter
topical analgesics

Principal Display Panel – 567 mg Box Label
Principal Display Panel – 567 mg Box Label

Principal Display Panel – 567 mg Patch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine Pain
Relief Patch

LIDOCAINE 4%

Topical Analgesic

Odor free

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

1 PATCH

3 15/16 IN X 5 ½ IN
(10 cm X 14 cm)

†Among over-the-counter
topical analgesics

Principal Display Panel – 567 mg Patch Label
Principal Display Panel – 567 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
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
66902-215-05CVS Health Lidocaine Pain Relief1 in 1 PATCHPATCH17
66902-215-05CVS Health Lidocaine Pain Relief5 in 1 BOXPATCH57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-215CVS HEALTH LIDOCAINE PAIN RELIEF (LIDOCAINE) PATCH [NATURAL ESSENTIALS, INC.]7Current NDC, Legacy NDC, 2 package rows20240206_52e82e70-53b7-4ecb-be39-fe10c94cc444.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
66902-21566902-215-05

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, UNSPECIFIEDFZ989GH94EIACT
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 Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact identifier
ndc (package): 66902-215-05
ndc (product): 66902-215
ndc11 (package): 66902021505
spl id: 23742710-543f-4479-ad04-60bbbeedc4ea
spl set id: 52e82e70-53b7-4ecb-be39-fe10c94cc444

Reported adverse events (FAERS/openFDA)#

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