MADECASSOL

Manufacturer
OASIS TRADING
Effective date
2018-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:33

Label at a glance#

ProductMADECASSOL
Active ingredientCENTELLA ASIATICA, NEOMYCIN SULFATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate, 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

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

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

DOSAGE & ADMINISTRATION SECTION

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72689-0017-12020-01-31C16284748780-19d75b9d0-6bf8-f424-e053-dadaa90a57ce7ca4d777-a28f-3cca-e053-2a91aa0a3ea3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0017-1MADECASSOL10 g in 1 TUBEOINTMENT101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0017MADECASSOL (NEOMYCIN SULFATE, TITRATED EXT. OF CENTELLA ASIATICA) OINTMENT [OASIS TRADING]1Legacy NDC, 1 package rows20181210_7ca4d777-a28f-3cca-e053-2a91aa0a3ea3.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
72689-001772689-0017-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
7ca4d777-a290-3cca-e053-2a91aa0a3ea37ca4d777-a28f-3cca-e053-2a91aa0a3ea32018-12-10WarningsExact identifier
spl id: 7ca4d777-a290-3cca-e053-2a91aa0a3ea3
spl set id: 7ca4d777-a28f-3cca-e053-2a91aa0a3ea3

Reported adverse events (FAERS/openFDA)#

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