THE ECZEMA- fucus vesiculosus, centella asiatica, aloe, melissa officinalis soap

THE ECZEMA by

Drug Labeling and Warnings

THE ECZEMA by is a Homeopathic medication manufactured, distributed, or labeled by Naples Soap Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THE ECZEMA 
fucus vesiculosus, centella asiatica, aloe, melissa officinalis soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69675-3273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	1 [hp_X]  in 1 g
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	1 [hp_X]  in 1 g
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69675-3273-7	75 g in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/01/2015

Labeler - Naples Soap Company (052273536)