FDA.reportPublic FDA data

Pain Relieving Liniment Spray

Manufacturer
J.R. Watkins, LLC.
Effective date
2024-04-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:33

Label at a glance#

ProductPain Relieving Liniment
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Provides penetrating pain relief temporarily relieves minor aches and pains of muscles and joints associated with simple backache strains bruises sprains arthritis

Dosage and administration

Adults and children 2 years and older: Apply to affected area not more than 3-4 times daily. Children under 2 years of age: Ask a doctor.

Storage and handling

do not use if full body shrink wrap is damaged or missing close container tightly and store at room temperature away from heat (dry, well-ventilated premises at 59-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
CAMPHOR 3.5%EXTERNAL ANALGESIC
MENTHOL 2.5%EXTERNAL ANALGESIC

Uses

INDICATIONS & USAGE SECTION

Provides penetrating pain relief

temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • strains
  • bruises
  • sprains
  • arthritis

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Flammable:Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

  • Adults and children 2 years and older: Apply to affected area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • do not use if full body shrink wrap is damaged or missing
  • close container tightly and store at room temperature away from heat (dry, well-ventilated premises at 59-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus globulus leaf oil, polysorbate 20, SD Alcohol 40B, thymol, water.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-243-9423

RECENT MAJOR CHANGES SECTION

Uses [Indications and Usage Section]

  • Added "Provides penetrating pain relifef" at the beginning of the section - change incorporated in 3/2024

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTD J.R. 1868

WATKINS

REMEDIES FOR BODY ®

PAIN RELIEVING
LINIMENT SPRAY

WITH MENTHOL & CAMPHOR

RELIEF FOR
SIMPLE BACKACHE,
ARTHRITIS, SPRAINS
& MUSCLE STRAINS

4 FL OZ (118 mL)

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2198969camphor 3.5 % / menthol 2.5 % Topical SprayPSN4
2198969camphor 35 MG/ML / menthol 25 MG/ML Topical SpraySCD4
2198969camphor 3.5 % / menthol 2.5 % Topical SpraySY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72342-050-19Pain Relieving Liniment118 mL in 1 BOTTLE, SPRAYSPRAY1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-050PAIN RELIEVING LINIMENT (CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM) SPRAY [J.R. WATKINS, LLC.]4Current NDC, Legacy NDC, 1 package rows20240403_97a0c839-0927-4e54-aee2-ded2016ac4a0.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-05072342-050-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
THYMOL3J50XA376EIACT
EUCALYPTUS OIL2R04ONI662IACT
POLYSORBATE 207T1F30V5YHIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
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 LinimentCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.97a0c839-0927-4e54-aee2-ded2016ac4a02024-04-02WarningsExact identifier
ndc (package): 72342-050-19
ndc (product): 72342-050
ndc11 (package): 72342005019
spl id: 142d99a3-82d9-758a-e063-6294a90ab7f5
spl set id: 97a0c839-0927-4e54-aee2-ded2016ac4a0

Reported adverse events (FAERS/openFDA)#

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