Other
Drug Facts
Other information: For use on mild to moderate eczema or psoriasis, or as directed by a physician.
Eczema And Psoriasis Therapy
FDA Label NDC 58666-3122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sundial Group Llc for the product Eczema And Psoriasis Therapy (NDC 58666-3122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, indications & usage, otc - ask doctor, otc - pregnancy or breast feeding, warnings, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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.
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
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