MADECASSOL

Manufacturer
Lydia Co., Ltd.
Effective date
2024-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:37

Label at a glance#

ProductMADECASSOL
Active ingredientCENTELLA ASIATICA
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titrated Ext. of Centella Asiatica

OTC - PURPOSE SECTION

temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

WARNINGS SECTION

Warnings

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Lavender oil, anhydrous ethanol, sodium hydroxide, purified water, propylene glycol.

DOSAGE & ADMINISTRATION SECTION

for topical use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0039-1MADECASSOL10 g in 1 TUBEGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0039MADECASSOL (CENTELLA ASIATICA) GEL [LYDIA CO., LTD.]1Current NDC, 1 package rows20240904_21307c5d-d34f-b95a-e063-6394a90a478f.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-003972988-0039-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
CENTELLA ASIATICA7M867G6T1UACTIB

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
MADECASSOLCENTELLA ASIATICALydia Co., Ltd.21307c5d-d34f-b95a-e063-6394a90a478f2024-09-03WarningsExact identifier
ndc (package): 72988-0039-1
ndc (product): 72988-0039
ndc11 (package): 72988003901
spl id: 213093ce-6854-cfd3-e063-6394a90a93fc
spl set id: 21307c5d-d34f-b95a-e063-6394a90a478f

Reported adverse events (FAERS/openFDA)#

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