FDA.reportPublic FDA data

CVS Pain Relieving Lotion RollOn

Manufacturer
CVS
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:46:58

Label at a glance#

ProductCVS Pain Relieving
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 5.5 %

Menthol 16 %

OTC - PURPOSE SECTION

Pain Relieving Lotion

INDICATIONS & USAGE SECTION

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

Arthritis

simple backache

strains

sprains

bruises

Provides penetrating pain relief

WARNINGS SECTION

For extranal use only

OTC - WHEN USING SECTION

avoid contact with eyes and mucous membranes

do not bandage tightly

do not use with a heating pad, medicated patch or other of local heat

do not apply to wounds or damaged, broken or irritated skin

OTC - STOP USE SECTION

condition worsens or irritation develops

pain, swelling or blistering develops where product was applied

redness or severe burning develops when product was applied

symptoms persist for more than 7 days or 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.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

Apply to affected area not more than 3 to 4 times daily

Wash hands with soap and water after use if product comes with hands

Children under 12 years of age

Ask a doctor

OTHER SAFETY INFORMATION

store between 20° - 25°C (68° - 77°F)

INACTIVE INGREDIENT SECTION

Carbomer, Clove Oil, Disodium EDTA, Eucalyptus Oil, Pentylene Glycol, Peppermint Oil, Phenoxyethanol, Polysorbate 80, SD Alcohol 40 B, Sorbitan Oleate, Tocopherol Acetate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package CartonPackage Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-885CVS PAIN RELIEVING (CAMPHOR 5.5% MENTHOL 16%) LOTION [CVS]3Legacy NDC20241213_d462a949-fe4e-ff80-e053-2995a90a2bc3.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-88551316-885-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
PENTYLENE GLYCOL50C1307PZGIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
CLOVE OIL578389D6D0IACT
ALCOHOL3K9958V90MIACT

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
471ac9ea-8a5b-4626-e063-6394a90a06dbd462a949-fe4e-ff80-e053-2995a90a2bc32025-12-29WarningsExact identifier
spl set id: d462a949-fe4e-ff80-e053-2995a90a2bc3

Reported adverse events (FAERS/openFDA)#

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