Active Ingredient
Colloidal Oatmeal 1%
Eczema Hand Relief Cream
FDA Label NDC 61328-010
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 Hand Relief (NDC 61328-010). 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 active ingredient, uses, purpose, warnings, keep out of reach of children, stop use and ask a doctor if, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.
Purpose
Skin protectant
Warnings
For external use only.
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Keep Out Of Reach Of Children
If swallowed get medical help or contact a poison control center right away.
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
Directions
Apply as needed to hands.
Inactive Ingredients
Water/Eau/Aqua, Vegetable Oil/Huile Végétale, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Stearyl Alcohol, Glyceryl Stearate, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Jojoba Oil/Macadamia Seed Oil Esters, Annona Cherimola Fruit Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Lecithin, Acetyl Glutamine, Lithothamnion Calcareum Extract, Folic Acid, Bacillus/Soybean Ferment Extract, Oligopeptide-3, Sodium Hyaluronate, Oligopeptide-2, Oligopeptide-1, Hexapeptide-11, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Trisodium Ethylenediamine Disuccinate, Citric Acid, Ethylhexylglycerin, Sodium Citrate, Propanediol, Pentylene Glycol, Phenylpropanol, Sodium Dehydroacetate, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol
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