FDA Label for Eczema And Psoriasis Therapy

View Indications, Usage & Precautions

Eczema And Psoriasis Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Sundial Group Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


Otc - Purpose



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.


Otc - Ask Doctor



Warnings:For external use only.


Otc - Pregnancy Or Breast Feeding



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


Warnings



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

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


Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


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.


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


Otc - Questions



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


Package Label.Principal Display Panel




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