FDA.reportPublic FDA data

Pain Relieving

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
Active ingredientCAMPHOR (NATURAL)
Label structure11 sections

Indications and uses

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

Dosage and administration

Lift silver tab to open Use only as directed Adults and children 2 years and older: Pat onto 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 tamper evident seal is not intact 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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

CAMPHOR 3.5%

Purpose

OTC - PURPOSE SECTION

EXTERNAL ANALGESIC

Uses

INDICATIONS & USAGE SECTION

for 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.

When using this product

OTC - WHEN USING SECTION

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

SPL UNCLASSIFIED SECTION

Flammable:Keep away from fire, sparks and heated surfaces

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heading pad

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

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

  • Lift silver tab to open
  • Use only as directed
  • Adults and children 2 years and older: Pat onto 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 tamper evident seal is not intact
  • close container tightly and store at room temperature away from heat (dry, well-ventilated premises at 59-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

capsicum oleoresin (chili pepper extract), potassium carbonate, potassium cocoate, SD alcohol 40B, spruce oil, water

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-384-1945

Do not use if tamper evident seal is not intact

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
J.R. WATKINS, LLC
Oakland, CA 94612

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTD
1868

J.R.
WATKINS
REMEDIES FOR BODY ®

PAIN RELIEVING
LINIMENT
EXTERNAL ANALGESIC

WITH CAMPHOR

SIMPLY RUB ONTO SKIN
FOR RELIEF

RELIEF FOR
SIMPLE BACKACHE,
ARTHRITIS, SPRAINS
& MUSCLE STRAINS

NOW DYE FREE

11 FL OZ (325 mL)

FL02317NR4

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
435780camphor 3.5 % Topical LotionPSN4
435780camphor 35 MG/ML Topical LotionSCD4
435780camphor 3.5 % Topical LotionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72342-040-25Pain Relieving325 mL in 1 BOTTLELINIMENT3254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72342-040PAIN RELIEVING (CAMPHOR (NATURAL)) LINIMENT [J.R. WATKINS, LLC.]4Current NDC, Legacy NDC, 1 package rows20240209_28821ffa-a138-47b5-8857-beadf7a20d43.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72342-04072342-040-25

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PICEA MARIANA LEAF OILQ1J49L1A5OIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
CAPSICUM OLEORESINUW86K581WYIACT
POTASSIUM CARBONATEBQN1B9B9HAIACT
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 RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
ndc (package): 72342-040-25
ndc (product): 72342-040
ndc11 (package): 72342004025
spl id: 10e0f078-977a-1a19-e063-6294a90a81e4
spl set id: 28821ffa-a138-47b5-8857-beadf7a20d43

Reported adverse events (FAERS/openFDA)#

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