Otc - Active Ingredient
Active ingredient Purpose
Colloidal Oatmeal 1% ..............................Skin Protectant
Eczema Therapy
FDA Label NDC 72381-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hamilton Therapeutics, Inc. for the product Eczema Therapy (NDC 72381-103). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporarily protects and helps relieve minor skin
irritation and itching due to: • Eczema • Rashes
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Indications & Usage
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
Warnings
Warnings For external use only. When using this product • Avoid contact with eyes.
Dosage & Administration
Directions • Apply as needed to affected areas.
• Use on mild to moderate eczema, or as directed by a physician.
Inactive Ingredient
Inactive ingredients Water, Butyrospermum Parkii (Shea) Butter, Bisabolol, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Honey, Sclerocarya Birrea Seed Oil, Glyceryl Stearate, Glycerin, Cetearyl Alcohol, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Potassium Cetyl Phosphate, Panthenol, Allantoin, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Niacinamide, Vegetable Oil, Sodium Hyaluronate, Xanthan Gum, Sodium PCA, Tetradecane, Arginine, Cetyl Phosphate, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.
Package Label.Principal Display Panel
Eczema Therapy
8 FL OZ/ 236mL
Eczema Thera Tube (Eczema Therapy 8oz Tube)
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