FDA.reportPublic FDA data

CVS Pro Menthol Gel

Manufacturer
CVS Pharmacy
Effective date
2026-03-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:26

Label at a glance#

ProductCVS Professional Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporarily relieves 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: rub a thin film over affected area not more than 3 to 4 times daily Children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves 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 excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or on mucous membranes
  • do not apply to wounds, damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional 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 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a physician

Other information

OTHER SAFETY INFORMATION

  • store at 20 - 25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Water

Principal Display Panel - 89 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS TM

NDC 51315-377-03

Professional

PAIN RELIEF ROLL-ON

Menthol 5%

Compare to Biofreeze ®

Professional Pain Relief

active ingredient*

Fast-Acting Pain Relief

Relieves Muscle Pain

Colorless Roll-On

3 FL OZ (89 mL)

Bottle labelBottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415975menthol 5 % Topical GelPSN2
415975menthol 0.05 MG/MG Topical GelSCD2
415975menthol 5 % Topical GelSY2

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-377-03CVS Professional Pain Relief89 mL in 1 BOTTLEGEL892

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-37751316-377-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRANKINCENSER9XLF1R1WMIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
ndc (package): 51316-377-03
ndc (product): 51316-377
ndc11 (package): 51316037703
spl id: 4ced3d77-539f-6493-e063-6394a90af257
spl set id: 48836a5b-0baa-b7ee-e063-6294a90ac12b

Reported adverse events (FAERS/openFDA)#

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