FDA.reportPublic FDA data

Pain Relieving Cooling Gel

Manufacturer
J.R. Watkins, LLC.
Effective date
2024-02-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:26

Label at a glance#

ProductPain Relieving 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 sprains

Dosage and administration

Use only as directed Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily. Children under 2 years of age: Ask a doctor. Wash hands carefully after using

Storage and handling

do not use if tamper evident seal is not intact 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 3%

Purpose

OTC - PURPOSE SECTION

EXTERNAL ANALGESIC

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable:Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heading pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash or irritation occurs

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

  • Use only as directed
  • Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.
  • Wash hands carefully after using

Other information

STORAGE AND HANDLING SECTION

  • do not use if tamper evident seal is not intact
  • store away from children
  • store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-384-1945

PRINCIPAL DISPLAY PANEL - 93 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRUSTED REMEDIES
SINCE 1868

ESTD
1868

J.R.
WATKINS
REMEDIES FOR BODY ®

PAIN RELIEVING
COOLING
GEL

WITH
NATURAL
MENTHOL

TEMPORARY
RELIEF FOR
MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)

PRINCIPAL DISPLAY PANEL - 93 g Tube Label
PRINCIPAL DISPLAY PANEL - 93 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN4
259150menthol 0.03 MG/MG Topical GelSCD4
259150menthol 3 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72342-020-93Pain Relieving Cooling93 g in 1 TUBEGEL934

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-020PAIN RELIEVING COOLING (MENTHOL, UNSPECIFIED FORM) GEL [J.R. WATKINS, LLC.]4Current NDC, Legacy NDC, 1 package rows20240209_3574d48a-b546-4ea7-b470-071bb328de64.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-02072342-020-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
TROMETHAMINE023C2WHX2VIACT
POLYSORBATE 60CAL22UVI4MIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
ndc (package): 72342-020-93
ndc (product): 72342-020
ndc11 (package): 72342002093
spl id: 10e16909-ec2f-f329-e063-6394a90a1453
spl set id: 3574d48a-b546-4ea7-b470-071bb328de64

Reported adverse events (FAERS/openFDA)#

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