FDA.reportPublic FDA data

LEADER Camphor Spirit

Manufacturer
Cardinal Health, 110 dba Leader | Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:28

Label at a glance#

ProductLEADER Camphor Spirit
Active ingredientCAMPHOR (NATURAL)
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

(Dillute with 3 parts olive oil and mix well)

Adults and children 2 yrs. and older apply to the affected area not more than 3 or 4 times daily.

Children under 2 yrs. of age: consult a doctor before use.

INACTIVE INGREDIENT SECTION

Alcohol 84%, Purified Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. In case of eye contact, flush eyes with running water for 15 minutes, get medical attention.

OTC - PURPOSE SECTION

External Analgesic

WARNINGS SECTION

For external use only.

Do not drink. If swallowed, immediately give 3 or 4 glasses of water. Do not induce vomiting. If vomiting occurs, give fluids again. Do not give anything by mouth to an unconscious or convulsing person. Get medical attention immediately.

Avoid contact with eyes or mucous membranes.

Do not apply to irritated skin.

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches, muscle and jooint pain associated with artritis, strains, bruises and simple backache

OTC - ACTIVE INGREDIENT SECTION

Camphor 10%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204935camphor spirit 10 % Topical SolutionPSN5
204935camphor 100 MG/ML Topical SolutionSCD5
204935camphor 10 % Concentrate for Topical SolutionSY5
204935camphor spirit 10 % Topical SolutionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0396-1LEADER Camphor Spirit59 mL in 1 BOTTLELIQUID595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0396LEADER CAMPHOR SPIRIT (CAMPHOR (NATURAL)) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20231223_7d3b0b28-5190-0622-e053-2991aa0af561.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0396-1ML - Milliliter70000-03965e22bfd2-684c-4b5e-91a6-f3ed937b7ea712019-08-06

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-039670000-0396-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
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
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
ndc (package): 70000-0396-1
ndc (product): 70000-0396
ndc11 (package): 70000039601
spl id: 0d197bc5-3780-1794-e063-6294a90a4123
spl set id: 7d3b0b28-5190-0622-e053-2991aa0af561

Reported adverse events (FAERS/openFDA)#

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