Active Ingredient
Colloidal Oatmeal (0.02%)
Gladskin Eczemact Eczema Cream
FDA Label NDC 73105-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Micreos North America, Inc. for the product Gladskin Eczemact Eczema (NDC 73105-003). 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, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
Warnings
For external use only.
Otc - When Using
When using this product do not get into eyes.
Otc - Stop Use
Stop use and ask a doctor if:
- Conditions worsen
- Symptoms last more than 7 days or clear up and occur again within a few days.
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.
Directions
- Apply as needed
Inactive Ingredients
Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Tromethamine, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)*
*Micreobalance™is a proprietary smart protein that rebalances the skin microbiome.
Questions?
(888) 802-1668
Company Information
Distributed by Micreos North America, Inc. Encinitas, CA 92024
gladskin.com
Product Packaging
1 (Eczemact)
* Please review the disclaimer below.
