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 00:10:10

Label at a glance#

ProductPain Relief Roll On Extra Strength, Cooling
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

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

Menthol 6%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of 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 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 menthol

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

Aloe barbadensis leaf extract, Arnica montana flower extract, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), water

Questions or Comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 79 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH*

ESTD 1868
J.R.
WATKINS
REMEDIES FOR BODY™

COOLING

PAIN RELIEF
ROLL-ON

USED BY
ATHLETES

WITH NATURAL MENTHOL,
ARNICA & VITAMIN E

FAST-ACTING
MENTHOL PAIN RELIEF
FOR BACKACHES,
SORE MUSCLES,
& JOINT PAIN

Net wt. 2.8 oz (79 g)

PRINCIPAL DISPLAY PANEL - 79 g Bottle Label
PRINCIPAL DISPLAY PANEL - 79 g Bottle Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-120PAIN RELIEF ROLL ON EXTRA STRENGTH, COOLING (MENTHOL, UNSPECIFIED FORM) GEL [J.R. WATKINS, LLC.]2Legacy NDC20240322_a455e126-4c5e-489c-9178-0f0636d76736.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-12072342-120-79

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
40bcef27-6b6f-5944-e063-6294a90a040aa455e126-4c5e-489c-9178-0f0636d767362025-10-09WarningsExact identifier
spl set id: a455e126-4c5e-489c-9178-0f0636d76736

Reported adverse events (FAERS/openFDA)#

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