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

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.

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Eczema and Psoriasis Therapy

Drug Facts

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

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

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.

Directions: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

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

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

Boxes

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)

Revised: 6/2013
Document Id: 62adc9c2-9915-4de3-9713-2c13b1b6fecc
Set id: 662687ca-4ced-4434-ac48-b0b1dd6346d3
Version: 1
Effective Time: 20130625
 
Sundial Group LLC