FDA.reportPublic FDA data

African Black Eczema Therapy

Manufacturer
Sundial Group LLC
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:52:00

Label at a glance#

ProductAfrican Black Eczema Therapy
Active ingredientCENTELLA ASIATICA, ALOE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Aloe (4X) HPUS.....................................Eczema
Hydrocotyle Asiatica (Tinc) HPUS.........Itching

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE SECTION

Uses:For temporary relief of the symptoms of mild eczema and itching.

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use is you havean overactive thyroid.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not useif pregnant, nursing, or for long term use.

WARNINGS SECTION

Avoid use in eyes or eye area. If irritation occurs, stop use.

OTC - STOP USE SECTION

Ask a doctor ifcondition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:Lather in hands or on a washcloth and wash body. Rinse thoroughly. Gentle enough for daily use.

SPL UNCLASSIFIED SECTION

Claims based on traditional homeopathic practice, not accepted medical advice. Not USFDA evaluated.

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Palmitic Acid, Avena Sativa (Oat) Kernel Meal, Avena Sativa (Oat) Kernel Flour, Carbon, Melaleuca Alternifolia (Tea Tree) leaf Oil, Sodium Chloride, Butyrospermum Parkii (Shea) Butter*, Sodium Shea Butterate, Alcohol, Theobroma Cacao (Cocoa) Pod Ash, Tetrasodium EDTA, Tetrasodium Etidronate, Sodium Cocoate, Salix Alba (Willow) Bark Extract, Salix Alba (Willow) leaf Extract, Phenoxyethanol, Fucus Vesiculosus Extract, Melissa Officinalis leaf Extract.

*Certified Organic Ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58666-3124-52024-10-17C16284748780-10191ceaa-675c-198a-e063-dbdaa90aec3eAfrican Black Eczema Therapy Bar Soap
58666-3124-52023-07-28C16284748780-10191ceaa-675c-198a-e063-dbdaa90aec3eAfrican Black Eczema Therapy Bar Soap

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58666-3124AFRICAN BLACK ECZEMA THERAPY (ALOE, CENTELLA ASIATICA) SOAP [SUNDIAL GROUP LLC]3Legacy NDC20241019_a62e577a-8f6a-e28d-e053-2995a90a8d99.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58666-312458666-3124-5

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SODIUM PALM KERNELATE6H91L1NXTWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PALMITIC ACID2V16EO95H1IACT
SHEA BUTTERK49155WL9YIACT
SALIX ALBA BARK205MXS71H7IACT
COCOAD9108TZ9KGIACT
OATMEAL8PI54V663YIACT
TEA TREE OILVIF565UC2GIACT
SODIUM CHLORIDE451W47IQ8XIACT
EDETATE SODIUMMP1J8420LUIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
FUCUS VESICULOSUS535G2ABX9MIACT
MELISSA OFFICINALISYF70189L0NIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM COCOATER1TQH25F4IIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
SODIUM PALMATES0A6004K3ZIACT
CENTELLA ASIATICA7M867G6T1UACTIB
ALOEV5VD430YW9ACTIB

Source Document#

Source XML

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24b19e39-3ea6-2f3d-e063-6394a90ac881a62e577a-8f6a-e28d-e053-2995a90a8d992024-10-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Ask a doctor before use is you have an overactive thyroid. Do not use if pregnant, nursing, or for long term use. Avoid use in eyes or eye area. If irritation occurs, stop use. Ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Avoid use in eyes or eye area. If irritation occurs, stop use.