Eczema Relief
FDA Label NDC 80551-301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acutens, Inc. for the product Eczema Relief (NDC 80551-301). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor if, otc - keep out of reach of children, pregnancy, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Colloidal Oatmeal 1.00%

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

  • do not get into eyes.
  • to avoid slipping, use mat in tub or shower.
  • in some skin conditions, soaking too long may over dry.

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

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

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Ceramide NG, Chamomilla Matricaria (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus
(Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Other Information

Protect the product in this container from excessive heat and direct sun.

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