Label: THE ECZEMA- fucus vesiculosus, centella asiatica, aloe, melissa officinalis 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 January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Fucus Vesiculosus (Tinc)
    Hydrocotyle Asiatica (Tinc)
    Aloe (3x)
    Melissa Officinalis (3x)

    Fucus Vesiculosus - For eczema and psoriasis

    Hydrocotyle Asiatica - For acne, rosacea, and itching

    Aloe - Humectant

    Melissa Officinalis - Reduces irritation; anti-bacterial/viral

  • INDICATIONS & USAGE

    Uses: Reduce and relieve itching and irritation due to:

    • eczema
    • psoriasis
    • chronic dry skin
  • WARNINGS

    Warnings
    For external use only.

    If you are pregnant or breastfeeding, consult a physician first.

    If problem worsens or symptoms of allergic reaction occur, discontinue use and contact a physician for further evaluation of condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Use with water to create lather and wash the body, then rinse thoroughly.
    Use twice dally for optimum results. Safe for use on face, avoid contact with eyes

  • SPL UNCLASSIFIED SECTION

    Other information: Naples Soap Company, 1200 5th Avenue South, Naples, FL 34102

  • INACTIVE INGREDIENT

    Inactive ingredients: Sodium Palmate, Water/Aqua, Sodium Cocoate, Glycerin, Avena Sativa (Oat) Kernel Flour, Cocos Nucifera (Coconut) Oil, Sodium Citrate, Alcohol, Yogurt Extract, Sodium Chloride

  • QUESTIONS

    Questions? 1-888-256-8265 or visit www.naplessoap.com

  • PRINCIPAL DISPLAY PANEL

    Box

    THE ECZEMA SOAP

  • INGREDIENTS AND APPEARANCE
    THE ECZEMA 
    fucus vesiculosus, centella asiatica, aloe, melissa officinalis soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69675-3273
    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 OFFICINALIS3 [hp_X]  in 1 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    COW MILK (UNII: 917J3173FT)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    OATMEAL (UNII: 8PI54V663Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69675-3273-775 g in 1 PACKAGE; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/01/2015
    Labeler - Naples Soap Company (052273536)
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