Otc - Active Ingredient
Active Ingredients
Colloidal oatmeal 0.1%
Dimethicone 2%
Pediadermics Eczema 3 Cream
FDA Label NDC 76348-580
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Pediadermics Eczema 3 (NDC 76348-580). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, 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
Skin protectant
Indications & Usage
Uses
Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.
Warnings
Warnings
For external use only
Otc - When Using
When using this product
- Do not get into eyes
- Do not apply before bathing or showering
Otc - Stop Use
Stop use and ask a doctor if
Condition worsens
- Symptoms last more than 2 weeks or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
For best results, follow the rule of "3"
- Apply liberally to skin at least "3" times a day
- Apply within "3" minutes of bathing
- Keep a "3" location supply (Home, On-the-Go and School) !
Inactive Ingredient
Inactive Ingredients
1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum
Other Safety Information
Other information
Store at room temperature.
Otc - Questions
Questions?
Statement Of Identity
eczema 3
skin barrier repair cream
Package Label.Principal Display Panel
ECZEMA 3 tube artwork
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