FDA Label for African Black Eczema Therapy
View Indications, Usage & Precautions
African Black Eczema 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.
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Drug Facts
Claims based on traditional homeopathic practice, not accepted medical advice. Not USFDA evaluated.
Otc - Purpose
Aloe (4X) HPUS.....................................Eczema
Hydrocotyle Asiatica (Tinc) HPUS.........Itching
The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.
Indications & Usage
Uses: For temporary relief of the symptoms of mild eczema and itching.
Warnings
For external use only.
Avoid use in eyes or eye area. If irritation occurs, stop use.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Ask Doctor
Ask a doctor before use is you have an overactive thyroid.
Otc - Pregnancy Or Breast Feeding
Do not use if pregnant, nursing, or for long term use.
Otc - Stop Use
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 body. Rinse thoroughly. Gentle enough for daily use.
Inactive Ingredient
Sodium Palmate, Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Palmitic Acid, Avena Sativa (Oat) Kernel Meal, Avena Sativa (Oat) Kernel Flour, Carbon, Melaleuca Alternifolia (Tea Tree) leaf Oil, Sodium Chloride, Butyrospermum Parkii (Shea) Butter*, Sodium Shea Butterate, Alcohol, Theobroma Cacao (Cocoa) Pod Ash, Tetrasodium EDTA, Tetrasodium Etidronate, Sodium Cocoate, Salix Alba (Willow) Bark Extract, Salix Alba (Willow) leaf Extract, Phenoxyethanol, Fucus Vesiculosus Extract, Melissa Officinalis leaf Extract.
*Certified Organic Ingredient
Otc - Questions
Questions? 631-842-8800 or visit www.SheaMoisture.com
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