CVS Maximum Strength Cold and Hot Pain Relief

Manufacturer
CVS Health | Garcoa, Inc.
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:40

Label at a glance#

ProductCVS Maximum Strength Cold and Hot Pain Relief Topical Analgesic
Active ingredientMenthol, Unspecified Form
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pain muscles and joints associated with: ♦ simple backache ♦ arthritis ♦ strains ♦ bruises and sprains ♦ cramps

Dosage and administration

adults and children 12 years of age and older: ♦ apply generously to affected area ♦ massage into painful area until thoroughly absorbed into skin ♦ repeat if necessary, but not more than 3 to 4 times daily ♦ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 16.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pain muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises and sprains
  • cramps

Warnings

WARNINGS SECTION

For external use only. Test on a small patch of skin before applying generously.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • avoid contact with eyes
  • do not apply to wounds or damages skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices
  • if redness is present, discontinue and consult a doctor
  • if skin irritation occurs, discontinue use

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, as a health professional 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 and children 12 years of age and older:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat if necessary, but not more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Capsaicin, Citric Acid, Glycerin, Isopropyl Myristate, Propylene Glycol, Water.

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS
Health™

Compare to the active
ingredient in Icy Hot®*

MAXIMUM STRENGTH
Cold & Hot
PAIN RELIEF LIQUID

MENTHOL 16%

  • No mess
  • Strong, quick relief
  • Roller ball applicator
    keeps hands clean
  • Stain free & fast drying

Roll-on, easy
applicator

Actual Product Size
on Side Panel

2.5 FL OZ (73 mL)

PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton
PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866084menthol 16 % Topical SolutionPSN2
866084menthol 160 MG/ML Topical SolutionSCD2
866084menthol 16 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-374-062025-01-30C16284748780-12cef2736-64cf-d83d-e063-dadaa90ab31fCVS Maximum Strength Cold & Hot Pain Relief Liquid Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-374-01CVS Maximum Strength Cold and Hot Pain Relief Topical Analgesic73 mL in 1 CYLINDERLIQUID732
69842-374-06CVS Maximum Strength Cold and Hot Pain Relief Topical Analgesic1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-374CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) LIQUID [CVS HEALTH]2Legacy NDC, 2 package rows20220127_ebb2dbf7-39b7-4a55-94ca-a5c1f420c8c5.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-37469842-374-01, 69842-374-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
c70440e0-b2c3-48e2-ac1c-513891a4a278ebb2dbf7-39b7-4a55-94ca-a5c1f420c8c52022-01-25WarningsExact identifier
spl id: c70440e0-b2c3-48e2-ac1c-513891a4a278
spl set id: ebb2dbf7-39b7-4a55-94ca-a5c1f420c8c5

Reported adverse events (FAERS/openFDA)#

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