FDA.reportPublic FDA data

CVS Cold and Hot

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2018-05-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:57:24

Label at a glance#

ProductCVS Cold and Hot
Active ingredientLIDOCAINE, MENTHOL
Label structure9 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 to completely apply patch to affected area use 1 patch for ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

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.
  • 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

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 to completely apply patch to affected area
  • use 1 patch for up to 12 hours

SPL UNCLASSIFIED SECTION

Children 12 years or younger: ask a doctor

Other information

OTHER SAFETY INFORMATION

Store at room temperature – do not exceed 86º Fahrenheit, 30º Celsius.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminium Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Propylene Glycol, Polysorbate 80, Polyvinyl Pyrrolidone 90, Tartaric Acid , Tetrasodium Edetate, Titanium Dioxide, Urea, Water.

Principal Display Panel - Cold and Hot Patch Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

UP TO
12
HOURS

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes
    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

Package Contains 5 individually
wrapped Patches

5 PATCHES

3 5/16" x 5 1/2" (10 cm x 14 cm)

Principal Display Panel - Cold and Hot Patch Box Label
Principal Display Panel - Cold and Hot Patch Box Label

Principal Display Panel - Cold and Hot Patch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health™

Compare to the active ingredients
in IcyHot® Lidocaine Patch
Plus Menthol*

NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes
    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

1 PATCH

3 5/16" x 5 1/2" (10 cm x 14 cm)

Principal Display Panel - Cold and Hot Patch Label
Principal Display Panel - Cold and Hot Patch Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66902-218-052024-12-05C16284748780-1ba0f9c33-2378-a910-e053-dadaa90a0b85Drug Facts
66902-218-052021-01-29C16284748780-1ba0f9c33-2378-a910-e053-dadaa90a0b85Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66902-218-05EA - Each66902-2181b70877b-ac3f-41c9-a1a6-ddd7bf3a9a6b12020-06-05

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-21866902-218-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K90RDH86HJV5ZIACT
TARTARIC ACIDW4888I119HIACT
EDETATE SODIUMMP1J8420LUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
UREA8W8T17847WIACT
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
28792002-80bb-2ed5-e063-6394a90a29c2ebcc09c2-b3f9-4c6d-b523-e27a077b5cb22024-12-04WarningsExact identifier
spl set id: ebcc09c2-b3f9-4c6d-b523-e27a077b5cb2

Reported adverse events (FAERS/openFDA)#

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