FDA.reportPublic FDA data

CVS Cold and Hot Lidocaine Menthol Patch

Manufacturer
CVS Pharmacy
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-29 01:03:41

Label at a glance#

ProductCVS Cold and Hot Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM, LIDOCAINE
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 applied...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purposes

OTC - PURPOSE SECTION

Topical Anesthetic

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 or 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

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.
  • Children under 12 years of age: ask a doctor.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 3 15/16 IN x 5 1/2 IN Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51316-274-05

CVS TM

L

Maximum OTC Strength †

COLD & HOT

PAIN RELIEF

PATCH

LIDOCAINE

Lidocaine 4% | Menthol 1%

Compare to Icy Hot ® Lidocaine Patch

Plus Menthol active ingredients*

Densitizes

Aggravated Nerves

Easy to Apply

Fast Acting

5 LARGE PATCHES

3 15/16 IN X 5 1/2 IN

(10 cm X 14 cm) EACH

†Lidocaine concentration without a prescription,

among over-the-counter topical analgesics.

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

CartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428124918GTIN-13: 0050428124918
EAN-13: 0050428124918
GTIN-12: 050428124918
UPC-A: 050428124918
GTIN storage (14 digits): 00050428124918		234274 MNTH LIDO PTCH_5ct_CTN_R8.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 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-27451316-274-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
POVIDONEFZ989GH94EIACT
ALUMINUM GLYCINATE1K713C615KIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
KAOLIN24H4NWX5COIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
TARTARIC ACIDW4888I119HIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-11full-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
4a93970c-4ece-19d5-e063-6394a90ae71c4a93970c-4ecd-19d5-e063-6394a90ae71c2026-02-11WarningsExact identifier
spl set id: 4a93970c-4ecd-19d5-e063-6394a90ae71c

Reported adverse events (FAERS/openFDA)#

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