Active Ingredient
Colloidal Oatmeal 2%
Soteri Skin Baby Eczema Relief Cream Emulsion
FDA Label NDC 85265-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Soteri Skin, Inc for the product Soteri Skin Baby Eczema Relief Cream (NDC 85265-104). 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, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily protect and helps relieve minor skin irritation and itching due to: eczema
Purpose
Skin Protectant
Warnings
For external use only
When using this product
- do not get into eyes
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply twice per day, AM and PM and always after cleansing.
- Apply as needed.
Inactive Ingredients
Purified Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Helianthus Annuus (Sunflower) Oil, Cetearyl Alcohol, Cocos Nucifera
(Coconut) Oil, Lactobacillus Ferment, Ceteareth-20, Hydrolyzed Oat Protein, Dimethicone, Sodium Citrate, Niacinamide, Glutamic Acid, Aspartic Acid, Histidine, Citric Acid, Sodium Gluconate, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Sodium Lauroyl Lactylate, Cholesterol, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Phenoxyethanol, Disodium EDTA.
Package Label
* Please review the disclaimer below.
