Active Ingredient
Lanolin 27.22%
Dermact Ointment
FDA Label NDC 87541-882
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marie's Original Formulas Llc for the product Dermact (NDC 87541-882). 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, do not use, when using this product, stop use and ask 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
Purpose
Skin protectant
Uses
Temporarily protects minor cuts, scrapes, and burns.
Helps protect and relieve chapped, cracked, or irritated skin.
Helps protect against the drying effects of wind and cold.
Helps protect skin exposed to pressure, friction, shear, and prolonged moisture.
Warnings
For external use only.
Do Not Use
On deep or puncture wounds.
Animal bites.
Serious burns.
When Using This Product
Avoid contact with eyes.
Stop Use And Ask A Doctor If
Condition worsens.
Symptoms last more than 7 days.
Symptoms clear up and occur again within a few days.
Irritation develops.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the affected area before application.
Apply a thin layer to the affected area as needed.
May be covered with a sterile bandage.
Other Information
Store at 20°–25°C (68°–77°F).
Protect from excessive heat.
See container for lot number and expiration date.
Inactive Ingredients
Shea Butter, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Cera Alba (Beeswax), Zinc Oxide, Calendula Officinalis Flower Oil, Hypericum Perforatum Extract, Cetearyl Alcohol (and) Polysorbate 60, Echinacea Purpurea Extract, Cod Liver Oil, Hippophae Rhamnoides Fruit Oil, Aloe Barbadensis Leaf Extract, Hydrastis Canadensis Root Extract, Symphytum Officinale Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Squalene, Lavandula Angustifolia Oil, Myristica Fragrans Kernel Oil, Eugenia Caryophyllus Bud Oil, Juniperus Communis Fruit Oil, Ethacridine Lactate Monohydrate.
Questions Or Comments?
Call 1-888-48-MARIE
Package Label.Principal Display Panel
DERMACT
SKIN ULCER & PRESSURE SORES
Skin Protectant Ointment
Maximum Strength
Pressure Relief
Advanced Healing
Barrier Protection
Supports Skin Recovery
Lanolin 27.22%
Net Wt. 4 oz (118 mL)
For External Use Only
Front (Dermact)
* Please review the disclaimer below.
