Label: AFRICAN BLACK ECZEMA THERAPY- aloe, centella asiatica soap

  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Package

  • INGREDIENTS AND APPEARANCE
    AFRICAN BLACK ECZEMA THERAPY 
    aloe, centella asiatica soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58666-3123
    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) ALOE1 [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:58666-3123-6141 g in 1 PACKAGE; Type 0: Not a Combination Product09/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/24/2019
    Labeler - Sundial Group LLC (832783430)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!