Otc - Active Ingredient
Active Ingredient:
Dimethicone 2.0%
Ethereal Skin Calming Moisturizing Cream
FDA Label NDC 70990-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Donegal Bay Ltd for the product Ethereal Skin Calming Moisturizing Cream (NDC 70990-003). 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, indications & usage, warnings, 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
Purpose:
Skin Protectant
Indications & Usage
Uses:
Relieves and helps prevent dry, itchy skin. Specially formulated to moisturize, calm, and soothe your skin.
Warnings
Warnings:
For external use only
When using this product, avoid contacting with eyes
Otc - Stop Use
In case of accidental ingestion get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Direction:
Smooth over irritated, dry skin daily or as needed. For best results apply immediately after shower or/and bath.
Inactive Ingredient
Inactive Ingredients:
Water, Glycerin, Cetyl Palmitate, Mineral Oil, Colloidal Oatmeal, Caprylic/Capric Triglyceride, Octyldodecanol, Cetyl Alcohol, Glyceryl Stearate, PEG-40 Stearate, Carbomer, Sodium Hydroxide, Phenoxyethanol, Benzyl Alcohol, Methylparaben, Propylparaben, DMDM Hydantoin
Package Label.Principal Display Panel
Image Description (1)
* Please review the disclaimer below.
