ECZEMA AND PSORIASIS THERAPY- fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap

Eczema and Psoriasis Therapy by

Drug Labeling and Warnings

Eczema and Psoriasis Therapy by is a Homeopathic medication manufactured, distributed, or labeled by Sundial Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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

INGREDIENTS AND APPEARANCE

ECZEMA AND PSORIASIS THERAPY 
fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58666-3122
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	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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58666-3122-6	141 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2013

Labeler - Sundial Group LLC (832783430)