Home SPL Set DailyMed Eczema Dermatitis Relief Balm Eczema Dermatitis Relief Balm SPL v4 SPL SPL Set ID fb801d20-9bec-1c71-e053-6394a90a6e95 Route TOPICAL Published Effective Date 2023-05-15 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Oatmeal (5 g) Inactive Ingredients Sodium Citrate Polyhydroxystearic Acid (2300 Mw) Amylopectin, Unspecified Source Phenylpropanol Phytosteryl Macadamiate Potassium Sorbate Sodium Chloride Sodium Carbonate Sodium Benzoate Macadamia Seed Oil Glycereth-8 Esters Hexylene Glycol Lecithin, Soybean Glycerin Glyceryl Monostearate Shea Butter Helianthus Annuus Seed Wax Pentylene Glycol Phytosphingosine Hyaluronate Sodium Tocopherol Phymatolithon Calcareum Cetostearyl Alcohol Coco-caprylate/caprate Sorbitan Olivate Octyldodecanol Squalane Sodium Stearoyl Glutamate Zinc Oxide Sodium Lauroyl Lactylate Medium-chain Triglycerides Sodium Hydroxide Propanediol Castanea Sativa Leaf Sodium Copper Chlorophyllin Sodium Dehydroacetate Hexapeptide-11 Lactic Acid Ceramide 1 Water Triheptanoin Allantoin Squalene Caprylyl Glycol Cholesterol Xanthan Gum Ethylhexylglycerin Cetearyl Olivate Sunflower Oil Phenoxyethanol Carbomer Homopolymer, Unspecified Type Aceglutamide Ceramide Np Ceramide Ap Folic Acid Citric Acid Monohydrate Cherimoya Identifiers & Packaging Pill Appearance Color: green Marketing Status OTC MONOGRAPH DRUG Active Since 2023-10-01 Description Colloidal Oatmeal 5% Purpose Skin protectant Medication Information Purpose Skin protectant Description Colloidal Oatmeal 5% Uses Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema. Section 51945-4 Warnings For external use only. When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. Directions Apply as needed to face and body. Questions? 1.866.927.2783 Active Ingredient Colloidal Oatmeal 5% Inactive Ingredients Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol. 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 Keep Out of Reach of Children If swallowed get medical help or contact a poison control center right away. Structured Label Content Uses (USES) Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema. Section 51945-4 (51945-4) Purpose (PURPOSE) Skin protectant Warnings (WARNINGS) For external use only. When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. Directions (DIRECTIONS) Apply as needed to face and body. Questions? (QUESTIONS?) 1.866.927.2783 Active Ingredient (ACTIVE INGREDIENT) Colloidal Oatmeal 5% Inactive Ingredients (INACTIVE INGREDIENTS) Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol. Stop Use and Ask A Doctor If (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 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. 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When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.", "DIRECTIONS": "Apply as needed to face and body.", "QUESTIONS?": "1.866.927.2783", "ACTIVE INGREDIENT": "Colloidal Oatmeal 5%", "INACTIVE INGREDIENTS": "Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.", "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", "KEEP OUT OF REACH OF CHILDREN": "If swallowed get medical help or contact a poison control center right away."} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:08:10.763419 · Updated: 2026-03-14T23:12:20.443473