Otc - Active Ingredient
Active Ingredient: Colloid Oatmeal USP (0.8%)
Gentle Eczema Balm
FDA Label NDC 45765-5142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naterra International Inc. for the product Gentle Eczema Balm (NDC 45765-5142). 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 - keep out of reach of children, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose : Skin Protectant
Warnings
Warnings: For external use only
Stop use and ask 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
Indications & Usage
Uses :
* Temporary protects and helps relieve minor skin irritation and itching due to * eczema
Dosage & Administration
Direction ; Apply as needed
Inactive Ingredient
Fragrance
* Please review the disclaimer below.
