FDA.reportPublic FDA data

CVS Lidocaine Pain Relief

Manufacturer
CVS Pharmacy
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:50:03

Label at a glance#

ProductCVS Lidocaine Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM, LIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves minor pain

Dosage and administration

adults and children 12 years of age and older: apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily massage until thoroughly absorbed into skin wash hands thoroughly with soap and water after each use children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

Purposes

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Flammable

  • keep away from heat and open flame

Do not use

OTC - DO NOT USE SECTION

  • in large quantities
  • on wounds or on irritated or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present of excessive skin irritation occurs
  • you experience severe burning pain, swelling, or blistering when the product was applied

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional 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 of age and older:
  • apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily
  • massage until thoroughly absorbed into skin
  • wash hands thoroughly with soap and water after each use
  • children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • avoid storing product in direct sunlight
  • store at 20-25°C (68-77°F)
  • Protect product from excessive moisture
  • Store with lid closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysilicone-11, polysorbate 60, propanediol, SD Alcohol 40-2, steareth-21, water.

Principal Display Panel - 147.8 mL Total Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health ®

Compare to the active ingredeints in IcyHot ® Max Lidocaine ‡

MAXIMUM STRENGTH

Lidocaine concentration without a prescription †

Lidocaine Pain Relief Roll-On

Lidocaine HCl 4%

Menthol 1%

  • Safe & effective
  • Fast acting & long lasting
  • Desensitizes aggravated nerves

TWIN PACK

†Under OTC external analgesic monograph.

Actual Bottle Size on Side Panel

2 x 2.5 FL OZ (73.9 mL)

5 FL OZ (147.8 mL) TOTAL

CartonCarton

Principal Display Panel - 73.9 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health ®

Compare to the active ingredients in IcyHot ®

Lidocaine Plus Menthol*

Maximum Strength

Lidocaine concentration

without a prescription †

Lidocaine Pain Relief Roll-On

Plus Menthol

Lidocaine HCl 4%

Menthol 1%

  • Safe & effective
  • Fast acting & long lasting
  • Desensitizes aggravated nerves

†Among over the counter topical analgesics.

Actual Bottle Size on Side Panel

2.5 FL OZ (73.9 mL)

Carton LabelCarton Label

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428059159GTIN-13: 0050428059159
EAN-13: 0050428059159
GTIN-12: 050428059159
UPC-A: 050428059159
GTIN storage (14 digits): 00050428059159		795031 Carton-1.jpg
BarcodeEAN-130050428607008GTIN-13: 0050428607008
EAN-13: 0050428607008
GTIN-12: 050428607008
UPC-A: 050428607008
GTIN storage (14 digits): 00050428607008		cvs0c-0001-01.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
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
51316-795-01CVS Lidocaine Pain Relief1 in 1 CARTONCREAM13
51316-795-01CVS Lidocaine Pain Relief73.9 mL in 1 BOTTLECREAM73.93
51316-795-02CVS Lidocaine Pain Relief73.9 mL in 1 BOTTLECREAM73.93
51316-795-02CVS Lidocaine Pain Relief2 in 1 CARTONCREAM23

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-79551316-795-02, 51316-795-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
METHYLPARABENA2I8C7HI9TIACT
CETEARYL ALCOHOL2DMT128M1SIACT
STEARETH-2153J3F32P58IACT
AMINOMETHYL PROPANOLLU49E6626QIACT
POLYSORBATE 60CAL22UVI4MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
EDETATE DISODIUM7FLD91C86KIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
DICETYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
ISOHEXADECANE918X1OUF1EIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
CETETH-20 PHOSPHATE921FTA1500IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-24monthly-update2026-06-03 17:56:48

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 Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
ndc (package): 51316-795-02
ndc (package): 51316-795-01
ndc (product): 51316-795
ndc11 (package): 51316079502
ndc11 (package): 51316079501
spl id: 4cd51c5d-aa06-2147-e063-6394a90a271a
spl set id: 48c045ae-56b5-62c2-e063-6394a90aaf44

Reported adverse events (FAERS/openFDA)#

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