Earth Mama Eczema Cream
FDA Label NDC 72812-151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Earth Mama Angel Baby, Llc for the product Earth Mama Eczema Cream (NDC 72812-151). 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, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Colloidal Oatmeal* 5%

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. For use on mild to moderate eczema or as directed by a physician.

Warnings

For External Use Only

When using this product: • do not get into eyes

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 product is swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply as needed.

Other Information

Store at room temperature.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Caprylic/Capric Triglyceride*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Butyrospermum Parkii (Shea) Butter*, Simmondsia Chinensis (Jojoba) Seed Oil*, Oenothera Biennis (Evening Primrose) Oil*, Aloe Barbadensis Leaf Powder*, Aspalathus Linearis (Rooibos) Leaf Extract*, Nigella Sativa (Black Cumin) Seed Extract*, Tocopherol, Zinc Oxide

*Organic

Questions Or Comments?

503-607-0607 or earthmama.com

Packaging

Image (72812 151 01)

Image (72812 151 01)

* Please review the disclaimer below.