FDA.reportPublic FDA data

Pain Relief Roller

Manufacturer
Better Living | Product Quest Mfg
Effective date
2018-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:03

Label at a glance#

ProductPain Relief Roller Signature Care
Active ingredientMenthol
Label structure7 sections

Indications and uses

For the temporary relief from minor aches and pains of soar muscles and joints associated with arthritis, backache, strains and sprains

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                        Purpose
Menthol 4%...............................................................Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief from minor aches and pains of soar muscles and joints associated with arthritis, backache, strains and sprains

WARNINGS SECTION

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame
When using this product  • avoid contact with eyes or mucouse membranes•do not apply to wounds or damaged skin • do not apply to the irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within
a few days.

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 immediately

DOSAGE & ADMINISTRATION SECTION

Directions
Shake well. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of
age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract
Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Calendula Officinalis Extract
Camellia Sinensis Leaf Extract
Camphor
Carbomer
FD&C Blue #1
FD&C Yellow #5
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract
Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract
Silica
Tocopheryl Acetate
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-764-032020-01-31C16284748780-19d75b9cf-e4e6-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-764-03Pain Relief RollerSignature Care73 mL in 1 BOTTLEGEL731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-764PAIN RELIEF ROLLER SIGNATURE CARE (MENTHOL 4%) GEL [BETTER LIVING]1Legacy NDC, 1 package rows20180330_01ab3464-256a-4caa-9efb-c30c98dbe102.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-76421130-764-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
GlycerinPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
Isopropyl AlcoholND2M416302IACT
Isopropyl Myristate0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
de55d3c9-dffb-4889-b7f5-f7ba5f10b99f01ab3464-256a-4caa-9efb-c30c98dbe1022018-01-18WarningsExact identifier
spl id: de55d3c9-dffb-4889-b7f5-f7ba5f10b99f
spl set id: 01ab3464-256a-4caa-9efb-c30c98dbe102

Reported adverse events (FAERS/openFDA)#

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