FDA.reportPublic FDA data

Pain Relief Roll On

Manufacturer
Fit Life Health, LLC
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:41:19

Label at a glance#

ProductPain Relief Roll On
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, CAPSAICIN
Label structure8 sections

Dosage and administration

Directions: • Adults and children over 12 years old: apply to affected area – do not apply more than 4 times daily • Children 12 years or younger: Consult a doctor

Label contents#

Full prescribing information#

Inactive ingredients Section

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Natural Citrus Fiber,

Dimethicone, Isopropyl Alcohol, Jojoba Oil,

Phenoxyethanol, Simethicone, Water

Inactive IngredientsInactive Ingredients

Active Ingredient Section see CapsaicinLabel.jpg

OTC - ACTIVE INGREDIENT SECTION

Menthol 6%........................................ Topical Analgesic

Camphor 5%....................................... Topical Analgesic

Capsaicin 0.025%............................... Topical Analgesic

Active IngredientsActive Ingredients

Dosage And Administration

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Directions: • Adults and children over 12 years old:

apply to affected area – do not apply more than 4 times

daily • Children 12 years or younger: Consult a doctor

Warnings

WARNINGS SECTION

Warning And Precautions

Warnings and precautionsWarnings and precautions

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of aches and pains of

muscles and joints associated with arthritis,

backaches, strains or sprains

UsageUsage

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

Keep out of reach of children: If ingested, get
medical help or contact Poison Control Center
immediately: 1-800-222-1222

Keep Out of Reach of ChildrenKeep Out of Reach of Children

Purpose Section

OTC - PURPOSE SECTION

For the temporary relief of aches and pains of

muscles and joints associated with arthritis,

backaches, strains or sprains

Primary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Label

Temporary Relief of Primary_LabelPrimary_Label

aches and pains

3 FL OZ (88 ML)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionPSN1
2610122camphor 50 MG/ML / capsaicin 0.25 MG/ML / menthol 60 MG/ML Topical SolutionSCD1
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84890-282-03Pain Relief Roll On87 g in 1 PACKAGELIQUID871

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84890-282PAIN RELIEF ROLL ON (TOPICAL ANALGESIC) LIQUID [FIT LIFE HEALTH, LLC]11 package rows20241210_26531b44-d066-d31a-e063-6394a90afc08.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84890-28284890-282-03
79804-282

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CITRUS FRUITXDK00Z8012IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
CAPSAICINS07O44R1ZMACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
ndc (product): 79804-282
26531b44-d067-d31a-e063-6394a90afc0826531b44-d066-d31a-e063-6394a90afc082024-11-07WarningsExact identifier
spl id: 26531b44-d067-d31a-e063-6394a90afc08
spl set id: 26531b44-d066-d31a-e063-6394a90afc08

Reported adverse events (FAERS/openFDA)#

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