Otc - Active Ingredient
Organic Colloidal Oatmeal 0.8% ... Skin Protectant
Eczacalm
FDA Label NDC 65112-250
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 Eczacalm (NDC 65112-250). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, inactive ingredient, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Otc - Keep Out Of Reach Of Children
WARNING: Keep out of reach of children.
Indications & Usage
Temporarily protects and helps relieve minor skin irritation and itching due to:
Eczema, rashes, insect bites, poison ivy, oak or sumac
Inactive Ingredient
Organic Safflower Oil, Organic Beeswax, Organic Rosehip Seed Oil, Organic Flax Oil, Vitamin E From Sunflowers, Organic Horsetail, Organic Comfrey, Organic Horsetail, Organic Aloe, Organic Calendula, Organic Burdock, Organic Licorice Root, Organic Chamomile, Organic St. John’s Wort, Organic Plantain.
Warnings
For external use only.
Do not use on:
deep puncture wounds
serious burns
animal bites
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
Dosage & Administration
Apply as needed
Package Label.Principal Display Panel
drug panel
* Please review the disclaimer below.
