AFRICAN BLACK ECZEMA THERAPY- aloe, centella asiatica soap 
Sundial Group LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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African Black Eczema Therapy Bar Soap

Drug Facts

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.

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

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.

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

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

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

Carton

AFRICAN BLACK ECZEMA THERAPY 
aloe, centella asiatica soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58666-3124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA1 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE4 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58666-3124-5141 g in 1 PACKAGE; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/21/2020
Labeler - Sundial Group LLC (832783430)

Revised: 1/2023
Document Id: f1a09874-c067-a317-e053-2a95a90a7efc
Set id: a62e577a-8f6a-e28d-e053-2995a90a8d99
Version: 2
Effective Time: 20230106
 
Sundial Group LLC