FDA.reportPublic FDA data

CVS Health Pain Relief

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:53:17

Label at a glance#

ProductCVS Health Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains

Dosage and administration

Adults and children 12 years of age and over: apply to affected area using roller ball not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

WARNINGS SECTION

For external use only

Flammable:Keep away from fire or flame and heated surfaces

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irritated skin
  • with a heating pad or TENS device

OTC - WHEN USING SECTION

When using this product

  • Use only as directed
  • do not bandage tightly
  • avoid contact with eyes or mucous membranes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask 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

SPL UNCLASSIFIED SECTION

Adults and children 12 years of age and over:

  • apply to affected area using roller ball not more than 4 times daily
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

SPL UNCLASSIFIED SECTION

Children under 12 years of age:

  • consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camellia Sinensis (Green Tea) Extract, Camphor, Caprylic/Capric Triglyceride, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water

Principal Display Panel - 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health ®

Compare to the active
ingredient in Biofreeze ®
Pain Relief Roll-On*

Pain Relief
Roll-On

MENTHOL 4%

  • Fast-acting pain relief
  • Relieves muscle pain
  • Soothes aggravated nerves
  • Vanishing scent

2.5 FL OZ (74 mL)

Principal Display Panel - 74 mL Bottle Label
Principal Display Panel - 74 mL Bottle Label

Principal Display Panel - 89 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health ®

Compare to the active
ingredient in Biofreeze ®
Pain Relief Gel*

Pain
Relief
Gel

MENTHOL 4%

  • Fast-acting pain relief
  • Relieves muscle pain
  • Soothes aggravated nerves
  • Vanishing scent

3 FL OZ (89 mL)

Principal Display Panel - 89 mL Tube Label
Principal Display Panel - 89 mL Tube Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-920CVS HEALTH PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [NATURAL ESSENTIALS, INC.]2Legacy NDC20241006_0fc3d308-17a1-4b5d-b56f-a664f0389203.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-92066902-920-03, 66902-920-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
23a8395d-34bb-272c-e063-6394a90aac290fc3d308-17a1-4b5d-b56f-a664f03892032024-10-04WarningsExact identifier
spl id: 23a8395d-34bb-272c-e063-6394a90aac29
spl set id: 0fc3d308-17a1-4b5d-b56f-a664f0389203

Reported adverse events (FAERS/openFDA)#

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