Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide 12%...............................Skin Protectant
Novana Protect Barrier
FDA Label NDC 76077-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Novana Medical Llc for the product Novana Protect Barrier (NDC 76077-300). 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, warnings and precautions, otc - keep out of reach of children, instructions for use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings And Precautions
Warnings
For external use only.
When using this product • Do not get in eyes. Stop use and ask doctor if •condition worsens • symptoms last more than 7 days or clear up and occur again within a few days. Do not use on • deep or puncture wounds • animal bites • serious burns
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
Directions • Apply as needed
Inactive Ingredient
Inactive ingredients
Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water
* Please review the disclaimer below.
