FDA.reportPublic FDA data

Pain Relief Roll-On

Manufacturer
J.R. Watkins, LLC.
Effective date
2024-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:11

Label at a glance#

ProductPain Relief Roll-On Muscle
Active ingredientCAMPHOR (NATURAL)
Label structure10 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area not more 4 times a day Massage painful area until absorbed into skin Wash hands after each use with cold water Children under 12 years of age: consult a doctor.

Storage and handling

Store away from children Store in dry, well-ventilated conditions at room temperature (59-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 1.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

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

  • On open wounds, damaged or irritated skin
  • With a heading pad or TENS device
  • With any other creams, ointments, sprays, liniments, or other topical products containing camphor

When using this product

OTC - WHEN USING SECTION

  • Do not bandage tightly
  • Use only as directed
  • Avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Rash, itching, redness, or excessive irritation of skin develops
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older:
  • Apply to affected area not more 4 times a day
  • Massage painful area until absorbed into skin
  • Wash hands after each use with cold water
  • Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store away from children
  • Store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica montana flower extract, cholecalciferol, denatured alcohol, ethylhexylglycerin, glycerin, hydroxyethylcellulose, magnesium chloride hexahydrate, Mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 20, water

Questions or Comments?

OTC - QUESTIONS SECTION

J.R. WATKINS, LLC
OAKLAND, CA 94612
1-888-384-1945
JRWATKINS.COM

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTD 1868
J.R.
WATKINS
REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF
ROLL-ON

USED BY
ATHLETES

WITH NATURAL MAGNESIUM,
VITAMIN D, CAMPHOR
& PEPPERMINT

PENETRATING
PAIN RELIEF FOR
MUSCLE STRAINS
AND SORENESS,
AND ACHING JOINTS

Net wt. 3.0 oz (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2469135camphor 1.5 % Topical GelPSN2
2469135camphor 0.015 MG/MG Topical GelSCD2
2469135camphor 1.5 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72342-190-85Pain Relief Roll-OnMuscle85 g in 1 BOTTLE, WITH APPLICATORGEL852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-190PAIN RELIEF ROLL-ON MUSCLE (CAMPHOR (NATURAL)) GEL [J.R. WATKINS, LLC.]2Current NDC, Legacy NDC, 1 package rows20240322_d94ae654-ce25-4bff-b9bd-24a0e0e8568a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-19072342-190-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CHOLECALCIFEROL1C6V77QF41IACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB

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
Pain Relief Roll-On MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.d94ae654-ce25-4bff-b9bd-24a0e0e8568a2024-03-20WarningsExact identifier
ndc (package): 72342-190-85
ndc (product): 72342-190
ndc11 (package): 72342019085
spl id: 141d0d83-daa9-ca8a-e063-6394a90aacfb
spl set id: d94ae654-ce25-4bff-b9bd-24a0e0e8568a

Reported adverse events (FAERS/openFDA)#

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