Warnings
For external use only
When using this product for the first time
-do an allergy patch test
Stop use and ask a Doctor if
-condition worsens
Keep out of reach of children
Atopis Med
FDA Label NDC 65112-269
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I Shay Cosmetics Inc for the product Atopis Med (NDC 65112-269). 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 warnings, uses, indications & usage section, otc active ingredient section, keep out of reach of children, dosage & administration, inactive ingredients, box, 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 irritation and itching due to rashes, eczema, insect bites
Indications & Usage Section
Uses temporarily protects and helpsrelieve minor skin irritation and itching due to rashes eczema insect bites
Directions Apply twice daily for best results
Otc Active Ingredient Section
Colloidal Oats 0.5%
Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Apply twice daily for best results.
Inactive Ingredients
Water, Myrecil, Olivem 1000, Cetearyl alcohol, Endmusol 20D, Macadamia oil, Safflower oil, Shea butter, glycerin, Harakeke gel, Geogard 221, Hyaluronic acid, Lavender oil, Tocopherol acetate, Manuka oil, Manuka honey, Citric acid, Xantham gum
* Please review the disclaimer below.
