Purpose
Skin Protectant
The following Structured Product Label (SPL) was submitted to the FDA by Marie's Original Formulas Llc for the product Dermasporin (NDC 87541-507). 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 purpose, usage, warnings, keep out of reach of children, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Skin Protectant
• Helps temporarily protect minor cuts, scrapes, and burns.
For external use only.
Do not use
• On deep or puncture wounds.
• On animal bites.
• On serious burns.
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.
If swallowed, get medical help or contact a Poison Control Center right away.
• Clean the affected area.
• Apply as needed.
• May be covered with a sterile bandage.
Store at 20°–25°C (68°–77°F).
See box or tube for lot number and expiration date.
Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Oil, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Butter, Emulsifying Wax NF, Echinacea Purpurea Extract, Ethacridine Lactate Monohydrate, Hippophae Rhamnoides (Sea Buckthorn) Extract, Hydrastis Canadensis Root Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Juniperus Communis Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Oleum Morrhuae (Cod Liver) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Symphytum Officinale (Comfrey) Extract, Tocopheryl Acetate, Syzygium Aromaticum (Clove) Oil, Zinc Oxide.
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www.marieoriginals.com
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