FDA.reportPublic FDA data

Pain Relief Spray Extra Strength, Cooling

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 00:10:09

Label at a glance#

ProductPain Relief 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
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120 deg. F

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • you have sensitive skin
  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: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, denatured alcohol, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, 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 - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH*

ESTD
1868
J.R.
WATKINS
REMEDIES FOR BODY™

COOLING

PAIN RELIEF SPRAY

WITH NATURAL MENTHOL,
ARNICA & VITAMIN E

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

4.0 fl oz (118 mL)

USED BY
ATHLETES

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-130PAIN RELIEF EXTRA STRENGTH, COOLING (MENTHOL, UNSPECIFIED FORM) AEROSOL, SPRAY [J.R. WATKINS, LLC.]2Legacy NDC20240322_92805cde-44d8-4962-9b65-e31e2d7ad4ee.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-13072342-130-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
.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
40bcf504-a903-e2d1-e063-6294a90a5de292805cde-44d8-4962-9b65-e31e2d7ad4ee2025-10-09WarningsExact identifier
spl set id: 92805cde-44d8-4962-9b65-e31e2d7ad4ee

Reported adverse events (FAERS/openFDA)#

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