Serawise Eczema Rescue Cream
FDA Label NDC 85050-575

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 Rescue (NDC 85050-575). 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, when using this product, stop use and consult a doctor if, keep out of reach of children., if pregnant or breast-feeding,, 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 duee 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 (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

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