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

Key Label Information#

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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

Other Label Information

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

OTC - QUESTIONS SECTION

Questions? 631-842-8800 or visit www.SheaMoisture.com

Label Images#

SM_ABS_EczemaTherapyBarSoap_270409_02_68408083
SM_ABS_EczemaTherapyBarSoap_270409_02_68408083

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#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

WARNINGS SECTION

For external use only.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions? 631-842-8800 or visit www.SheaMoisture.com

Source Document#

Source XML