Serawise Eczema Relief Cream
FDA Label NDC 85050-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dranamaria. Com Llc for the product Serawise Eczema Relief (NDC 85050-012). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and consult a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Colloidal oatmeal 1%
Purpose
Skin protectant
Uses
temporarily protects and helps relieve minor skin irritation and itching due to: ▪ rashes ▪ eczema ▪ poison ivy, oak, or sumac ▪ insect bites
Warnings
For external use only
When Using This Product
- do not get into eyes.
Stop Use And Consult 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
Apply As Needed
Other Information
Keep away from excessive heat and direct sun.
Inactive Ingredients
Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (Vit B12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum (St. John's Wort) Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).
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