FDA.reportPublic FDA data

CVS Pain Relief

Manufacturer
CVS Pharmacy
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-11 01:01:11

Label at a glance#

ProductCVS Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 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 2 years of age and older: apply over affected areas not more than 4 times daily; massage as necessary. Children under 2 years of age: Consult a physician

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

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

Use only as directed

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin.
  • Do not use wiht other ointments, creams, sprays, or liniments
  • Do not apply to irritated skin or if excessive skin irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Store in a cool, dry place

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a physician before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek professional help and contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply over affected areas not more than 4 times daily; massage as necessary.

Children under 2 years of age: Consult a physician

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 TM

PAIN RELIEF

ROLL-ON

Menthol 4%

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

Fast-acting pain relief

Relieves muscle pain

Vanishing scent

2.5 FL OZ (74 mL)

610722 Roll On610722 Roll On

Principal Display Panel - 89 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51316-933-03

CVS TM

Pain Relief Gel

MENTHOL 4%

Compare to Biofreeze ® Pain Relief Gel active ingredient*

Fast-acting pain relief

Relieves muscle pain

Vanishing scent

3 FL OZ (89 mL)

Tube LabelTube Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428124307GTIN-13: 0050428124307
EAN-13: 0050428124307
GTIN-12: 050428124307
UPC-A: 050428124307
GTIN storage (14 digits): 00050428124307		665933 PAIN RL TUBE.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-93351316-933-03, 51316-933-25

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FRANKINCENSER9XLF1R1WMIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-06-15daily-update2026-06-18 05:10:12
12026-02-12full-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
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
ndc (package): 51316-933-03
ndc (package): 51316-933-25
ndc (product): 51316-933
ndc11 (package): 51316093325
ndc11 (package): 51316093303
spl id: 587589b3-7714-fab2-e063-6394a90a1d11
spl set id: 4aa629f5-8b8f-cc67-e063-6394a90a019f

Reported adverse events (FAERS/openFDA)#

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