AFRICAN BLACK ECZEMA THERAPY- aloe, centella asiatica soap

African Black Eczema Therapy by

Drug Labeling and Warnings

African Black Eczema Therapy by is a Homeopathic medication manufactured, distributed, or labeled by Sundial Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Aloe (1X) 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

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

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.

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AFRICAN BLACK ECZEMA THERAPY 
aloe, centella asiatica soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58666-3123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	1 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITIC ACID (UNII: 2V16EO95H1)
SHEA BUTTER (UNII: K49155WL9Y)
SALIX ALBA BARK (UNII: 205MXS71H7)
COCOA (UNII: D9108TZ9KG)
OATMEAL (UNII: 8PI54V663Y)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
MELISSA OFFICINALIS (UNII: YF70189L0N)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM COCOATE (UNII: R1TQH25F4I)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
SODIUM PALMATE (UNII: S0A6004K3Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58666-3123-6	141 g in 1 PACKAGE; Type 0: Not a Combination Product	09/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/24/2019

Labeler - Sundial Group LLC (832783430)