Otc - Active Ingredient
colloidal oatmeal 2%
Eczema Intensive Daily Relief Body Cream
FDA Label NDC 61328-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinfix, Inc. for the product Eczema Intensive Daily Relief Body (NDC 61328-210). 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, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - stop use, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.
Otc - Purpose
Skin protectant
Warnings
For external use only.
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Otc - Keep Out Of Reach Of Children
If swallowed get medical help or contact a poison control center right away.
Otc - Stop Use
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Dosage & Administration
Apply generously to affected areas.
Inactive Ingredient
Water/Eau/Aqua, Glycerin, Triheptanoin, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Cetyl Stearate, Caprylyl Caprylate/Caprate, Annona Cherimola Fruit Extract, Glyceryl Stearate, Jojoba Oil/Macadamia Seed Oil Esters, Stearyl Alcohol, Vegetable Oil/Huile Végétale, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Acetyl Glutamine, Lecithin, Lithothamnion Calcareum Extract, Hexapeptide-11, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Folic Acid, Oligopeptide-3, Oligopeptide-1, Oligopeptide-2, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Citric Acid, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Tocopherol, Sodium Citrate, Propanediol, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol.
Otc - Questions
1.866.927.2783
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