Otc - Active Ingredient
Zinc Oxide 15%
Barrier Balm Ointment
FDA Label NDC 75523-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Project Chemistry, Inc. for the product Barrier Balm (NDC 75523-200). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Warnings
Warnings:
For external use only.
Otc - When Using
When using this product, avoid wounds and contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or doesn't improve
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.
Dosage & Administration
Directions:
Apply a thin layer as needed to clean, dry skin.
Inactive Ingredient
Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.
Indications & Usage
To help prevent and relieve skin irritation from wetness.
Package Label.Principal Display Panel
Ina (Ina)
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