Label: AFRICAN BLACK ECZEMA THERAPY- aloe, centella asiatica soap
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Contains inactivated NDC Code(s)
NDC Code(s): 58666-3123-6 - Packager: Sundial Group LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated September 24, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
AFRICAN BLACK ECZEMA THERAPY
aloe, centella asiatica soapProduct 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)