Label: ECZEMA AND PSORIASIS THERAPY- fucus vesiculosus, centella asiatica, melissa officinalis, aloe 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 June 25, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Fucus Vesiculosus Extract - (Tinc)Remedy for eczema
    Centella Asiatica Extract - (Tinc)Reduces itching
    Melissa Officinalis Extract - (Tinc)Reduces irritation
    Aloe Socotrina Extract - (1X)Humectant
  • INDICATIONS & USAGE

    Uses: Temporarily protects and helps relieve minor skin irritation and itching due to: rash, eczema, poison ivy, oak or sumac, insect bites.

  • WARNINGS

    Warnings:For external use only.

    Not to be used during pregnancy. Not to be used while nursing.

    Therapeutic use is not recommended in hyperthyroidism; long-term therapeutic use is not recommended. When using this product do not get into eyes.

    Stop use and 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 entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

  • SPL UNCLASSIFIED SECTION

    Other information: For use on mild to moderate eczema or psoriasis, or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients: Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Palmitic Acid, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus, (Sunflower) Seed Oil (and) Salix Alba (Willow) Bark Extract, Saponified Butyrospermum Parkii (Shea) Butter, Saponified Cocos Nucifera, (Coconut) Oil, Saponified Elaeis Guineensis (Palm) Kernel Oil, Cocoa Pod Ash, Avena Sativa (Oat) Kernel Meal, Carbon, Avena Sativa (Oat) Kernel Flour, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride, Tetrasodium EDTA, Tetrasodium Etidronate.

    *Certified Organic Ingredient

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Boxes

  • INGREDIENTS AND APPEARANCE
    ECZEMA AND PSORIASIS THERAPY 
    fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58666-3122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS1 [hp_X]  in 1 g
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA1 [hp_X]  in 1 g
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS1 [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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PALM OIL (UNII: 5QUO05548Z)  
    COCOA (UNII: D9108TZ9KG)  
    OATMEAL (UNII: 8PI54V663Y)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58666-3122-6141 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2013
    Labeler - Sundial Group LLC (832783430)
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