FDA.reportPublic FDA data

COCA LIEF

Manufacturer
INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:29

Label at a glance#

ProductCOCA LIEF
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure7 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol ........... 1.5 mg ..... Topical Analgesic
Methyl Salicylate 12.5 mg ..... Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Temporary relief of aches and pains associated with <Arthritis, Carpal Tunnel, Swelling, Sprains, Brusing and Inflamation

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use.

INDICATIONS & USAGE SECTION

For External Use Only

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding consult a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens or if sympotoms last for more than 7 days, or if condition clears up but occurs again a few days later, or if you dicsover a rash/irritation.

OTHER SAFETY INFORMATION

Store at 66 to 92 degress Farenheit. Do not leave in direct sunlight.

DOSAGE & ADMINISTRATION SECTION

aPPLY 3 TO 4 TIMES DAILY AS NEEDED

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Trolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISPLAY PANELDISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84831-096-01COCA LIEF100000 mg in 1 TUBEGEL1000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84831-096COCA LIEF (MENTHOL, METHYLSALICYLATE) GEL [INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.]11 package rows20250120_2bedd2d0-b430-1844-e063-6294a90a965f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84831-09684831-096-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
CARBOMER 9404Q93RCW27EIACT
ERYTHROXYLUM COCA LEAFD052HE394VIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB
ALCOHOL 95%7528N5H79BIACT

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
2bedd2d0-b431-1844-e063-6294a90a965f2bedd2d0-b430-1844-e063-6294a90a965f2025-01-17WarningsExact identifier
spl id: 2bedd2d0-b431-1844-e063-6294a90a965f
spl set id: 2bedd2d0-b430-1844-e063-6294a90a965f

Reported adverse events (FAERS/openFDA)#

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